ABIOMED Impella 5.5 Heart Pump Introducer Sheath Leakage Risk Recall
Abiomed is recalling the Impella 5.5 Smart Assist Set heart pump due to potential leakage from introducer sheaths. The defect is not visually detectable and affects all affected pump sets worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a critical implantable medical device (heart pump). Class I recalls meet the "Severe" threshold (minimum score 4) per the rubric, particularly for life-sustaining devices where leakage could compromise device function or patient safety.
Plain-English summary
Abiomed, Inc. is recalling the ABIOMED Impella 5.5 Smart Assist Set (Pump Set Codes 1000211, 1000212) due to a potential for introducer sheath leakage. The leakage may occur under the sheath cap and along the hub score lines in both 14Fr and 23Fr introducers. Since 14Fr or 23Fr introducers are provided in every pump set, all units are potentially affected.
The manufacturing issues causing this leakage are not visually detectable by users, meaning affected units cannot be identified by inspection alone. A total of 383 units have been distributed worldwide, including across the US and to 33 additional countries including Australia, Canada, Japan, and multiple European nations.
Patients and healthcare facilities using the affected Impella 5.5 pump sets should contact Abiomed, Inc. for guidance on remediation options. This is a Class I recall by the FDA.
The recalled product
- Product
- ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
- Manufacturer
- Abiomed, Inc.
- Affected units
- 383
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Pump Set Codes 1000211
- 1000212
Distribution
Part of a larger recall action
This product is one of 13 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · Abiomed, Inc.
See all →- HighAbiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects
FDA (Devices) · 2026-09-30
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Flag Component Failure
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereABIOMED Impella CP Heart Pump Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22
Same hazard · device leakage
See all →- SevereABIOMED Impella RP Flex heart pump introducer sheath leakage risk
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella 5.5 SmartAssist S2 heart pump introducer sheath leakage risk
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella CP Introducer Kit 14Fr heart pump safety recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella Introducer Kit Recalled Due to Potential Leakage
FDA (Devices) · 2026-07-22
- HighIntera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall
FDA (Devices) · 2026-07-01
Similar recalls
- SevereAbiomed Impella Introducer Kit Recalled Due to Potential Leakage
FDA (Devices) · 2026-07-22
- SevereAbiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk
FDA (Devices) · 2026-07-22
- SevereImpella 5.5 with SmartAssist Catheter Recalled for Heightened Purge Leak Rate
FDA (Devices) · 2023-05-24
- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella 5.5 pump recalled due to impeller blade damage risk
FDA (Devices) · 2023-07-26
- ModerateAbiomed Impella 5.5 Recall for Potential Shockwave Catheter Interaction
FDA (Devices) · 2024-09-11