Maquet Cardiovascular LLC
Wayne, NJ, US
Maquet Cardiovascular LLC appears in FDA device records in Wayne, NJ. FDA records list 14 510(k) clearances between and , 12 PMA records and one registered establishment. As of , FDA records show 277 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Maquet Cardiovascular LLC 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.
- CTS, Inc. dba Guidant Cardiac Surgeryrecall
- Guidant Cardiac Surgeryrecall
510(k) clearance history
FDA records hold 14 510(k) clearances for Maquet Cardiovascular LLC between 2008 and 2026. The busiest year on record is 2013, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2016 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252445 | Fusion Bioline Vascular Graft | DSY | Substantially Equivalent | |
| K251238 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010) | GEI | Substantially Equivalent | |
| K243918 | Vasoview Hemopro 3 Power Supply | GEI | Substantially Equivalent | |
| K233879 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) | GEI | Substantially Equivalent | |
| K191930 | 7 mm Extended Length Endoscope | GCJ | Substantially Equivalent | |
| K191947 | VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord | GEI | Substantially Equivalent | |
| K153194 | VASOVIEW HemoPro Endoscopic Vessel Harvesting System | GEI | Substantially Equivalent | |
| K153523 | FUSION Vascular Graft | DSY | Substantially Equivalent | |
| K132743 | HARVESTING CANNULA | GEI | Substantially Equivalent | |
| K131778 | FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K122612 | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX | MAL | Substantially Equivalent | |
| K101274 | VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | Substantially Equivalent | |
| K091733 | VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 | GEI | Substantially Equivalent | |
| K082725 | GRAFTGUARD PRESSURE CONTROLLING SYRINGE | GBX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2242352 | 2242352 | Maquet Cardiovascular LLC | 45 BARBOUR POND DRIVE, Wayne, NJ 07470 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GBXCatheter, Irrigation
- DXCClamp, Vascular
- FZTCutter, Surgical
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- MALGraft, Vascular, Synthetic/Biologic Composite
- DWSInstruments, Surgical, Cardiovascular
- GCJLaparoscope, General & Plastic Surgery
- FQHLavage, Jet
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter
- MWSStabilizer, Heart
Recall records
Showing 25 of 277| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2741-2026 | The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274. | Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026. | Class II | Open, Classified | |
| Z-2588-2025 | Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder. | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. | Class II | Open, Classified | |
| Z-2587-2025 | Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder. | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. | Class II | Open, Classified | |
| Z-2586-2025 | Heartstring III Proximal Seal System. Intravascular anastomosis occluder. | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis. | Class II | Open, Classified | |
| Z-2636-2025 | Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting Tool features two curved, insulated jaws with heating elements that operate through heat and pressure rather than radiofrequency energy. | Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws. | Class II | Open, Classified | |
| Z-1622-2025 | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope, C-Ring, distal lens washer tube, and Harvesting Tool for cutting and cauterizing vessel branches. The Harvesting Tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning the device, cutting, and cauterization are performed under endoscopic visualization. The device is intended for specific use with the VASOVIEW HEMOPRO Power Supply, VASOVIEW HEMOPRO 2 extension cable, and an adapter cable. | There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025. | Class II | Open, Classified | |
| Z-1577-2025 | Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2). | Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up. | Class II | Open, Classified | |
| Z-0712-2025 | Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting. | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool | Class I | Open, Classified | |
| Z-0711-2025 | VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting. | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool | Class I | Open, Classified | |
| Z-0486-2025 | Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z | Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. | Class II | Open, Classified | |
| Z-0485-2025 | Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z | Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. | Class II | Open, Classified | |
| Z-0484-2025 | Acrobat-i Positioner. Model Number C-XP-5000Z | Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life. | Class II | Open, Classified | |
| Z-0092-2025 | VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500 | There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. | Class I | Open, Classified | |
| Z-2338-2024 | The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. | There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue. | Class II | Open, Classified | |
| Z-2337-2024 | The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. | There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue. | Class II | Open, Classified | |
| Z-2176-2024 | The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. | Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended. | Class II | Open, Classified | |
| Z-2175-2024 | The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Number: VH-4000. 2. VasoView Hemopro 2 with Vasoshield. Model Number: VH-4001. The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. | Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended. | Class II | Open, Classified | |
| Z-0710-2024 | Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death. | Class I | Open, Classified | |
| Z-0709-2024 | Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection | Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death. | Class I | Open, Classified | |
| Z-0724-2024 | Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. | Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery. | Class II | Open, Classified | |
| Z-0723-2024 | Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . | Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery. | Class II | Open, Classified | |
| Z-0589-2024 | Acrobat-i Vacuum Positioner System, Model Number XP-5000Z | The Positioner Arm may not tighten or lock during normal use. | Class II | Open, Classified | |
| Z-0210-2024 | Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2). | Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device. | Class II | Open, Classified | |
| Z-0137-2024 | Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z | Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion. | Class II | Open, Classified | |
| Z-2274-2023 | ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery. | The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain