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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- Hazard
- device-leakage
- manufacturing-defect
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
Distributed nationwide across the United States.
Related recalls
Same category
- ModeratePhotera 400 Phototherapy Device Recalled for Incorrect UV Sensor Calibration
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- ModeratePapablic Replacement Brush Heads Recalled Due to Breakage Risk
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 Phototherapy Device UV Sensor Calibration Error
FDA (Devices) · 2026-07-22