Abiomed, Inc.
Danvers, MA, US
ABIOMED, INC. appears in FDA device records in Danvers, MA. FDA records list 19 510(k) clearances between and , 190 PMA records and one registered establishment. As of , FDA records show 86 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 19 510(k) clearances for Abiomed, Inc. between 1989 and 2025. The busiest year on record is 2020, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252766 | 14Fr Low Profile Introducer Kit | DYB | Substantially Equivalent | |
| K241708 | Abiomed 14Fr Low Profile Introducer Kit | DYB | Substantially Equivalent | |
| K221294 | preCARDIA Occlusion System | MJN | Unknown | |
| K223161 | OXY-1 System | DTZ | Substantially Equivalent | |
| K222113 | Abiomed 14Fr Low Profile Introducer Set | DYB | Substantially Equivalent | |
| K202330 | Impella XR Sheath Set | DYB | Substantially Equivalent | |
| K200109 | OXY-1 System | DTZ | Substantially Equivalent | |
| K201116 | Abiomed 23 Fr Sheath | DYB | Substantially Equivalent | |
| K192769 | Impella CP Introducer | DYB | Substantially Equivalent | |
| K112892 | IMPELLA 2.5 PLUS CATHETER | PBL | Unknown | |
| K110845 | IMPELLA CONTROLLER WITH FLOW CONTROL | KFM | Substantially Equivalent | |
| K093801 | IMPELLA CONTROLLER | KFM | Substantially Equivalent | |
| K083111 | IMPELLA 5.0 CATHETER FAMILY | KFM | Substantially Equivalent | |
| K063723 | IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM | KFM | Substantially Equivalent | |
| K070225 | SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE | DSP | Substantially Equivalent | |
| K062582 | SUPRACOR BALLOON CATHETER | DSP | Substantially Equivalent | |
| K911643 | ABIODENT PERIOTEMP(R) SYSTEM | EIL | Substantially Equivalent | |
| K900574 | ABIOMED BODY LEAD ANALYZER MODEL 200/20 | JAO | Substantially Equivalent | |
| K885075 | ABIOMED PERIOTEMP(TM) PROBE | EIL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1220648 | 1220648 | ABIOMED, INC. | 22 Cherry Hill Dr, DANVERS, MA 01923 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- MJNCatheter, Intravascular Occluding, Temporary
- DWAControl, Pump Speed, Cardiopulmonary Bypass
- KMKDevice, Intravascular Catheter Securement
- EILGauge, Depth, Instrument, Dental
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- OUGMedical Device Data System
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- JAOScanner, Fluorescent
- DSPSystem, Balloon, Intra-Aortic And Control
- OZDTemporary Non-Roller Type Left Heart Support Blood Pump
- PYXTemporary Non-Roller Type Right Heart Support Blood Pump
Recall records
Showing 25 of 86| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2693-2026 | ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2692-2026 | ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2691-2026 | ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2690-2026 | ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2689-2026 | ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2688-2026 | ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2687-2026 | ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2686-2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2685-2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2684-2026 | ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2683-2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2682-2026 | ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2681-2026 | ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. | Class I | Open, Classified | |
| Z-2602-2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542. | Potential for thrombus formation during prolonged use of the introducer. | Class I | Open, Classified | |
| Z-2601-2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834. | Potential for thrombus formation during prolonged use of the introducer. | Class I | Open, Classified | |
| Z-2600-2026 | Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435. | Potential for thrombus formation during prolonged use of the introducer. | Class I | Open, Classified | |
| Z-2599-2026 | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434. | Potential for thrombus formation during prolonged use of the introducer. | Class I | Open, Classified | |
| Z-2457-2026 | Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. | Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. | Class I | Open, Classified | |
| Z-2360-2026 | Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 7. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US. 13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP. 16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices. | Class I | Open, Classified | |
| Z-2211-2026 | Automated Impella Controller (AIC); Product Code: 0042-0000-US; | A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures. | Class I | Open, Classified | |
| Z-1589-2026 | Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040). 5. Impella RP Pump Set, EU; Product Code: 0046-0011. 6. Impella CP Pump Set, EU; Product Code: 0048-0002. 7. Impella CP Pump Set BR; Product Code: 0048-0002-BR. 8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below). 9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044. 10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014). 11. Impella 5.0 IMC Pump Set EU; Product Code: 005060. 12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002. 13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004. 14. 5.5 Accessories AU; Product Code: 1000362. 15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014). | Increased risk of purge leaks with Generation 1 purge cassettes. | Class I | Open, Classified | |
| Z-1591-2026 | Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. | Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps. | Class I | Open, Classified | |
| Z-1471-2026 | Impella RP. Product Code: 0046-0011. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. | Class I | Open, Classified | |
| Z-1470-2026 | Impella RP Flex with SmartAssist. Product Code: 1000323. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. | Class I | Open, Classified | |
| Z-1469-2026 | Impella RP with SmartAssist. Product Code: 0046-0035. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. | Class I | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain