Browse Device Recalls
56 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 56 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 56 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| May 31, 2024 | Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left hear... | Nine (9) Impella CP pumps failed inspection and were inadvertently released. | Class I | Abiomed, Inc. |
| Dec 27, 2023 | Impella catheters - Intravascular micro axial blood pumps that support a pati... | IFU has been updated to include warnings about the risk of the inlet perforating through the myoc... | Class I | Abiomed, Inc. |
| Dec 27, 2023 | Impella catheters - Intravascular micro axial blood pumps that support a pati... | New warnings are being added to the Instructions for Use for all affected products to reduce the ... | Class II | Abiomed, Inc. |
| Dec 6, 2023 | Impella Connect, software portal for online device management that allows cli... | The following features have been disabled from the web-based portal because the FDA has not evalu... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, ... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introd... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are ... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introdu... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introdu... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introdu... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Nov 7, 2023 | Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040,... | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the... | Class II | Abiomed, Inc. |
| Oct 10, 2023 | Automated Impella Controller (AIC), product number 0042-000-US with software ... | Pump not detected as connected to controller due to software issue. | Class II | Abiomed, Inc. |
| Oct 10, 2023 | Automated Impella Controller (AIC), product number 0042-040-US with software ... | Pump not detected as connected to controller due to software issue. | Class II | Abiomed, Inc. |
| Jun 29, 2023 | Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product ... | A higher than expected rate of thrombus formation or deposition has been observed. The risk is f... | Class I | Abiomed, Inc. |
| Jun 14, 2023 | Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Nu... | There is a potential risk for unintentional interaction of the Impella motor housing with the dis... | Class I | Abiomed, Inc. |
| Jun 14, 2023 | Impella CP intravascular micro axial blood pump, Product Number 0048-0032 | There is a potential risk for unintentional interaction of the Impella motor housing with the dis... | Class I | Abiomed, Inc. |
| Jun 14, 2023 | Impella 2.5 intravascular micro axial blood pump, Product Number 005042 | There is a potential risk for unintentional interaction of the Impella motor housing with the dis... | Class I | Abiomed, Inc. |
| Jun 14, 2023 | Impella CP with SmartAssist intravascular micro axial blood pump, Product Num... | There is a potential risk for unintentional interaction of the Impella motor housing with the dis... | Class I | Abiomed, Inc. |
| Jun 14, 2023 | Impella 5.0 intravascular micro axial blood pump, Product Number 005062 | There is a potential risk for unintentional interaction of the Impella motor housing with the dis... | Class I | 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.