FDA-Device2026-07-22Class IPROCESSING DEFECT
Abiomed Impella CP heart pump introducer recalled for potential sheath leakage
What this means
Abiomed has recalled the Impella CP heart pump introducer due to a manufacturing defect that can cause fluid leakage from under the sheath cap and along the hub. The defect is not visible to the user and affects all current batches worldwide.
- If you use or manage an Impella CP pump system, contact your Abiomed representative or healthcare provider immediately.
- Do not use affected introducers until you receive further guidance from Abiomed or your medical team.
- Retain all product documentation and batch information for identification.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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
87,277 units
Manufactured in
22 Cherry Hill Dr, Danvers, MA, United States
Products
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2682-2026More Abiomed recalls
- FDA-Device2026-09-30Abiomed Impella Controller recalled for firmware and software defects affecting pressure signal accuracy
- FDA-Device2026-09-23Abiomed Impella Optical Controller recalled for purge cassette recognition failure risk
- FDA-Device2026-09-23Abiomed Impella Optical Controller recalled for purge cassette recognition failure
- FDA-Device2026-09-23Abiomed Impella Controller recalled for purge cassette recognition failure risk
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.