FDA-Device2026-07-22Class IPROCESSING DEFECT
Abiomed Impella RP Flex heart pump recalled for introducer sheath leakage risk
OTHERNationwide distribution
Abiomed Impella RP Flex recalled for sheath leakage risk
The Abiomed Impella RP Flex heart pump set includes introducers that may leak fluid from under the sheath cap or along hub score lines due to manufacturing defects. These leaks cannot be seen by visual inspection. All current batches worldwide are affected.
- If you have an Impella RP Flex pump set, contact Abiomed immediately for guidance.
- Do not use the device until you receive instructions from Abiomed or your healthcare provider.
- Report any leakage or concerns to Abiomed and your hospital or clinic.
Hazard
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Sold states
Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (JP), Kuwait (KW), Luxembourg (LU), Malaysia (MY), Mexico (MX), Netherlands (NL), Norway (NO), Panama (PA), Poland (PL), Saudi Arabia (SA), Serbia (RS), Slovenia (SI), South Korea (KR), Spain (ES), Sweden (SE), Switzerland (CH), Taiwan (TW), Thailand (TH), United Arab Emirates (AE), and United Kingdom (GB).
Affected count
5,017 units
Manufactured in
22 Cherry Hill Dr, Danvers, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2681-2026Also reported as
- FDA-Device2026-07-22Abiomed Impella CP Introducer Kit recalled for potential sheath leakage
- FDA-Device2026-07-22Abiomed Insertion Kit heart pump accessory recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella CP Introducer Kit recalled for potential sheath leakage risk
More Abiomed, Inc. recalls
- FDA-Device2026-07-22Abiomed Impella CP heart pump introducer recalled for potential sheath leakage
- FDA-Device2026-07-22Abiomed Impella CP Introducer Kit recalled for potential fluid leakage
- FDA-Device2026-07-22Abiomed Impella CP heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella 5.5 SmartAssist S2 heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella 5.5 Smart Assist Set recalled for introducer sheath leakage risk
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