510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Boston Scientific Corporation

Coventry, RI, US

Boston Scientific Corporation appears in FDA device records in Coventry, RI. FDA records list 1,110 510(k) clearances between and , 7,037 PMA records and 22 registered establishments. As of , FDA records show 1,835 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1,110
PMA records
7,037
Recall records
1,835
Registered establishments
22

FDA records under these names

20 names

FDA records resolved to Boston Scientific Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Angiodynamics Inc. (Navilyst Medical Inc.)enforcement report, recall
  • AngioDynamics, Inc.registration, 510(k), enforcement report, recall
  • Aziyo Biologics, Inc.510(k), enforcement report, recall
  • Boston Scientific Corp., Marina Bay Cust. Fulfillment Centerregistration
  • Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538recall
  • Boston Scientific CRM Corpenforcement report, recall
  • Boston Scientific Marlbourghrecall
  • Boston Scientific Scimed, Inc.510(k), PMA, recall
  • Boston Scientific, Target510(k), recall
  • Bridgepoint Medical510(k), enforcement report, recall
  • C. R.Bard, Inc./BardElectrophysiology Divisionrecall
  • C. R.Bard, Inc./Electrophysiology Divisionrecall
  • Endochoice, Inc.510(k), enforcement report, recall
  • Guidant Corp-Cpi Divisionrecall
  • Guidant Corporation510(k), PMA, recall
  • Horizon Medical Products, Inc.510(k), recall
  • Navilyst Medical, Inc.510(k), enforcement report, recall
  • Navilyst Medical, Inc., an AngioDyamics Companyenforcement report, recall
  • Rita Medical Systems, Inc.510(k), recall
  • Symbiosis Corp.510(k), recall

510(k) clearance history

Showing 50 of 1,110

FDA records hold 1,109 510(k) clearances for Boston Scientific Corporation between 1988 and 2026. The busiest year on record is 2002, with 53. The most recent is 2026, with 13.

Clearances by year, as a table
510(k) clearance decisions for Boston Scientific Corporation, by decision year
YearClearances
19881
198911
199017
199113
199218
199327
199443
199533
199631
199743
199831
199927
200041
200139
200253
200352
200440
200530
200637
200717
200818
200922
201024
201137
201243
201335
201448
201538
201625
201736
201820
201922
202023
202121
202217
202329
202416
202518
202613
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K262406EluPro Antibiotic-Eluting BioEnvelopeFTMSubstantially Equivalent
K262462TheraSphere 360™ Y-90 Management PlatformLLZSubstantially Equivalent
K262165FARADRIVE™ Steerable Sheath (M004PF21M402)DRASubstantially Equivalent
K261488OBSIDIO Conformable EmbolicKRDSubstantially Equivalent
K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESWSubstantially Equivalent
K260428RIVOS™ EUS Access Device (M00553900)ODGSubstantially Equivalent
K260100MOSES Raydar™GEXSubstantially Equivalent
K260771TruSelect™ 2.6 MicrocatheterKRASubstantially Equivalent
K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)OBJSubstantially Equivalent
K251273Asurys Fluid Management SystemHIGSubstantially Equivalent
K253198NanoKnife Generator (H78720300351US0)OABSubstantially Equivalent
K260479TheraSphere 360™ Y-90 Management PlatformLLZSubstantially Equivalent
K260119SpaceOAR Vue System (SV-2101)OVBSubstantially Equivalent
K252509AlphaVac Multipurpose Mechanical Aspiration System F1885QEZSubstantially Equivalent
K253376OBSIDIO™ Conformable Embolic (M0013972101010)KRDSubstantially Equivalent
K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)GEXSubstantially Equivalent
K252547TheraSphere 360™ Y-90 Management PlatformLLZSubstantially Equivalent
K253106AngioVac CannulaDWFSubstantially Equivalent
K252910Orca Air/Water and Suction ValvesODCUnknown
K252921Radial Jaw 4 Pulmonary Biopsy ForcepsBWHSubstantially Equivalent
K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)FGBSubstantially Equivalent
K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)MXDSubstantially Equivalent
K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser FibersGEXSubstantially Equivalent
K251291Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and PushersFGESubstantially Equivalent
K250310VIKING™ Fixed Curve Diagnostic CatheterDRFSubstantially Equivalent
K250584Rezum SystemKNSSubstantially Equivalent
K251344OptiMap™ SystemDQKSubstantially Equivalent
K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetFADSubstantially Equivalent
K250517Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006FEDSubstantially Equivalent
K250468iSLEEVE Introducer SetDYBSubstantially Equivalent
K250066Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)PKLSubstantially Equivalent
K242950WallFlex Biliary PLUS RX Stent SystemFGEUnknown
K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)OABSubstantially Equivalent
K242960AdVance™ XP Male Sling System (720163-03)OTMSubstantially Equivalent
K240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterDRFSubstantially Equivalent
K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)GEHSubstantially Equivalent
K242507OBSIDIO™ Conformable EmbolicKRDSubstantially Equivalent
K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMVFGEUnknown
K241227RHYTHMIA HDx™ Mapping SystemDQKSubstantially Equivalent
K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H749390314LITSubstantially Equivalent
K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500)FGBSubstantially Equivalent
K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemESWSubstantially Equivalent
K233837Agile Esophageal Stent SystemESWSubstantially Equivalent
K240397AlphaVac MMA F1885 System (H787253020)QEZSubstantially Equivalent
K234002ICEfx Cryoablation System (FPRCH8000-02)GEHSubstantially Equivalent
K234046WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery SystemMQRSubstantially Equivalent
K240018WATCHMAN TruSteer Access System (M635TU90050)DQYSubstantially Equivalent
K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse DeflectionFGBSubstantially Equivalent
K233248FARADRIVE™ Steerable SheathDRASubstantially Equivalent
K23350314F iSLEEVE Introducer SetDYBSubstantially Equivalent

Registered establishments

FDA registered establishments for Boston Scientific Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30155370493015537049ANGIODYNAMICS, INC24 Native Dr, Queensbury, NY 12804 US2026
30178925103017892510ANGIODYNAMICS, INC8 Glens Falls Technical Park, Glens Falls, NY 12801 US2026
13192111319211ANGIODYNAMICS, INC.603 QUEENSBURY AVE., Queensbury, NY 12804 US2026and 15 more, listed in full below
10005231141000523114AngioDynamics, Inc.26 Forest St, Marlborough, MA 01752 US2026and 16 more, listed in full below
18281321828132BOSTON SCIENTIFIC CORPORATION780 BROOKSIDE DRIVE, SPENCER, IN 47460 US2026and 40 more, listed in full below
21342653002095335BOSTON SCIENTIFIC CORPORATIONTwo Scimed Place, Maple Grove, MN 55311 US2026and 35 more, listed in full below
30048592413004859241BOSTON SCIENTIFIC CORPORATION302 Parkway, Global Park, La Aurora Heredia -- CR2026and 25 more, listed in full below
30050998033005099803BOSTON SCIENTIFIC CORPORATION100 BOSTON SCIENTIFIC WAY, Marlborough, MA 01752 US2026and 104 more, listed in full below
30253414843025341484BOSTON SCIENTIFIC CORPORATIONZona Franca La Lima, Cartago 30106 CR2026
30325077963032507796BOSTON SCIENTIFIC CORPORATION11480 Lakefield Drive, Johns Creek, GA 30097 US2026and 3 more, listed in full below
12256873001451463Boston Scientific Corp., Marina Bay Cust. Fulfillment Center500 Commander Shea Boulevard, QUINCY, MA 02171 US2026and 42 more, listed in full below
10001210561000121056Boston Scientific Corporation8 Industrial Dr, Coventry, RI 02816 US2026and 116 more, listed in full below
21242152124215Boston Scientific Corporation4100 Hamline Ave N, Saint Paul, MN 55112 US2026and 159 more, listed in full below
26487292648729Boston Scientific CorporationNo. 12, RD. No. 698, Dorado, PR 00646 US2026and 9 more, listed in full below
30056198803005619880Boston Scientific Corporation1100 Old Ellis Rd, Roswell, GA 30076 US2026
30076959593007695959Boston Scientific Corporation2546 First Street, Propark, El Coyol Alajuela 20904 CR2026and 50 more, listed in full below
30107057683010705768Boston Scientific Corporation309 Waverley Oaks Rd., Waltham, MA 02452 US2026
30197516103019751610Boston Scientific Corporation2775 Matheson Blvd E, Mississauga Ontario L4W 4P7 CA2026
30273457943027345794Boston Scientific Corporation10700 Xylon Av N, Brooklyn Park, MN 55445 US2026No device listings on this registration
96166843002913962Boston Scientific LimitedBusiness and Technology Park, CORK Munster -- IE2026and 21 more, listed in full below
96166933002618605Boston Scientific LimitedCashel Road, CLONMEL Tipperary -- IE2026and 15 more, listed in full below
96812603002806565Boston Scientific LimitedBALLYBRIT BUSINESS PARK, GALWAY Galway(County) -- IE2026and 97 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Showing 25 of 1,835
Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-3083-2026LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.Class IIOpen, Classified
Z-3082-2026LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.Class IIOpen, Classified
Z-3081-2026LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.Class IIOpen, Classified
Z-2962-2026Suture Cinch Long 1pk. Endoscopic tissue approximation device.Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.Class IIOpen, Classified
Z-2961-2026OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.Class IIOpen, Classified
Z-2978-2026Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheterPotential for arterial sheath tip separation or partial tip separation during use.Class IOpen, Classified
Z-2977-2026Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheterPotential for arterial sheath tip separation or partial tip separation during use.Class IOpen, Classified
Z-2725-2026Rapid Refill Continuous Injection System, UPN M00566001Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.Class IIOpen, Classified
Z-2840-2026Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.Potential for breach in sterile barrier of device packaging.Class IIOpen, Classified
Z-2839-2026Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240cm Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.Potential for breach in sterile barrier of device packaging.Class IIOpen, Classified
Z-2838-2026Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.Potential for breach in sterile barrier of device packaging.Class IIOpen, Classified
Z-2771-2026Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.Class IIOpen, Classified
Z-2757-2026FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.Class IIOpen, Classified
Z-2756-2026FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.Class IIOpen, Classified
Z-2755-2026FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.Class IIOpen, Classified
Z-2754-2026FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.Class IIOpen, Classified
Z-2753-2026FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation CatheterBoston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.Class IIOpen, Classified
Z-2752-2026FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation CatheterLabeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.Class IIOpen, Classified
Z-2751-2026FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation CatheterLabeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.Class IIOpen, Classified
Z-2750-2026FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation CatheterLabeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.Class IIOpen, Classified
Z-2637-2026CRE Wireguided 18-20mm 240cmPotential sterile breach of the pouches in which devices are packaged.Class IIOpen, Classified
Z-2636-2026CRE Wireguided 15-18mm 240cmPotential sterile breach of the pouches in which devices are packaged.Class IIOpen, Classified
Z-2635-2026CRE Wireguided 12-15mm 240cmPotential sterile breach of the pouches in which devices are packaged.Class IIOpen, Classified
Z-2634-2026CRE Wireguided 10-12mm 240cmPotential sterile breach of the pouches in which devices are packaged.Class IIOpen, Classified
Z-2633-2026CRE Wireguided 8-10mm 240cmPotential sterile breach of the pouches in which devices are packaged.Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain