ABIOMED Impella RP Flex heart pump introducer sheath leakage risk
Abiomed is recalling the Impella RP Flex heart pump due to potential introducer sheath leakage from the sheath cap and hub score lines. The manufacturing defect is not visually detectable.
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: The FDA classified this as Class I, which per the rubric mandates a minimum score of 4. Although no reported illnesses or injuries are stated in the source text, the Class I designation for a life-sustaining cardiac device with a manufacturing defect affecting all units in the field justifies the Severe rating.
Plain-English summary
Abiomed, Inc. is recalling the ABIOMED Impella RP Flex with SmartAssist Set (Pump Set Code 1000323; introducer Product Code 2000342) worldwide. Approximately 5,017 units have been distributed across the US and 38 other countries including Canada, Australia, Japan, and countries throughout Europe.
The recall addresses a potential for introducer sheath leakage from under the sheath cap and along the hub score lines in both 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user. Because 14Fr or 23Fr Introducers are provided in every pump set, all current batches in the field are affected.
The source text does not specify reported illnesses, injuries, or deaths associated with this defect. Patients or healthcare providers who have questions about this recall or experience symptoms related to sheath leakage should contact their healthcare provider or Abiomed directly for guidance on next steps.
The recalled product
- Product
- 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
- Manufacturer
- Abiomed, Inc.
- Affected units
- 5,017
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 (1)
- Pump Set Code 1000323
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 5.5 Heart Pump Introducer Sheath Leakage Risk Recall
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
- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
FDA (Devices) · 2026-07-22
- CriticalImpella RP Flex Devices Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22
- SevereImpella RP Heart Pump Recalled Due to Optical Sensor Damage Risk
FDA (Devices) · 2025-01-22
- SevereImpella RP Flex cardiac pump recalled for thrombus formation risk
FDA (Devices) · 2023-08-09