Browse Device Recalls
79 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 79 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 79 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 11, 2026 | ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 2... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containi... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP;... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; co... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Produc... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containi... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; ... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, cont... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Produc... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Intro... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550,... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, cont... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| Jun 11, 2026 | ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella In... | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines... | Class I | Abiomed, Inc. |
| May 22, 2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 22, 2026 | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set ... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 22, 2026 | Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set ... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 22, 2026 | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected... | Potential for thrombus formation during prolonged use of the introducer. | Class I | Abiomed, Inc. |
| May 18, 2026 | Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, ... | Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms ... | Class I | Abiomed, Inc. |
| May 14, 2026 | Automated Impella Controller (AIC), for use with left heart support blood pum... | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction wi... | Class I | Abiomed, Inc. |
| Apr 20, 2026 | Automated Impella Controller (AIC); Product Code: 0042-0000-US; | A retrospective review identified that there are AIC units requiring specific hardware updates to... | Class I | Abiomed, Inc. |
| Feb 18, 2026 | Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labe... | Increased risk of purge leaks with Generation 1 purge cassettes. | Class I | Abiomed, Inc. |
| Feb 16, 2026 | Automated Impella Controller (AIC), labeled as the following with correspondi... | Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC... | Class I | Abiomed, Inc. |
| Jan 27, 2026 | Impella RP. Product Code: 0046-0011. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Jan 27, 2026 | Impella RP with SmartAssist. Product Code: 0046-0035. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Jan 27, 2026 | Impella RP Flex with SmartAssist. Product Code: 1000323. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Dec 4, 2025 | Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. | Device packaged in incorrect outer box carton. | Class II | Abiomed, Inc. |
| Oct 1, 2025 | Automated Impella Controller (AIC), used for left heart support blood pump, l... | Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella ... | Class I | Abiomed, Inc. |
| Sep 16, 2025 | Automated Impella Controller (AIC) labeled as the following with correspondin... | Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer fail... | Class I | Abiomed, Inc. |
| Aug 20, 2025 | Automated Impella Controller (AIC) with the below brands and product codes. U... | Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not mee... | Class I | Abiomed, Inc. |
| Jun 23, 2025 | Automated Impella Controller (AIC), used in left heart support blood pump, in... | A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when ... | Class I | Abiomed, Inc. |
| Dec 12, 2024 | Impella RP with SmartAssist; Product Number: 0046-0035; | Optical Sensors have been damaged due to physical interaction between the inlet and another devic... | Class I | Abiomed, Inc. |
| Dec 12, 2024 | Impella RP Flex with SmartAssist; Product Number: 1000323; | Optical Sensors have been damaged due to physical interaction between the inlet and another devic... | Class I | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 Set AU; Product Code: 1000361; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Pump 371 14F LT CMR Set; Product Code: 0048-0045; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Pump Set, Japan; Product Code: 0048-0034-JP; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set, EU; Product Code: 0048-0014; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Pump 381 Pump Set (US); Product Code: 1000080; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set; Product Code: 1000402; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Smart Assist Set APAC; Product Code: 0048-0047; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.