FDA-Device2026-07-22Class IPROCESSING DEFECT
Abiomed Intro Kit heart pump introducer recalled for potential fluid leakage risk
OTHERNationwide distribution
Abiomed Intro Kit introducer recalled for leakage risk
Abiomed heart pump introducer sheaths in the Intro Kit may leak fluid from under the sheath cap or along the hub score lines. The manufacturing defect is not visible to users. All current batches of the kit worldwide are affected.
- If you use or manage an Abiomed Intro Kit, contact your healthcare provider or Abiomed immediately
- Do not use affected introducers until you have guidance from your medical team
- Check with your hospital or clinic for information on replacement or inspection procedures
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
96 units
Manufactured in
22 Cherry Hill Dr, Danvers, MA, United States
Products
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2693-2026More 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 RP Flex heart pump recalled for introducer sheath leakage risk
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