Abiomed Introducer Kit Sterile Barrier Compromise Due to Pouch Defect
Abiomed Introducer Kits may have holes in outer pouches that compromise sterility, exposing patients to bacterial contamination and risk of infection, bacteremia, or sepsis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—holes in the sterile barrier pouch of a vascular device—creates serious risk of bacterial infection and sepsis, but no adverse events have been reported. This meets the criteria for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Abiomed, Inc., is recalling the Abiomed Kit, 14Fr Introducer (Part Number 0052-3046), a component of Impella Catheter systems. Approximately 2,551 units have been distributed in the United States and multiple countries.
Holes in the outer pouches of affected kits may compromise the sterile barrier. Non-sterile introducers expose patients to potential microorganism contamination through the vascular access site, which can lead to infection, bacteremia, or sepsis.
This is an FDA Class II medical device recall. The FDA has assigned recall number Z-0652-2024. Healthcare providers with affected kits should review the FDA recall notice for further information and instructions.
The recalled product
- Product
- Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046
- Manufacturer
- Abiomed, Inc.
- Hazard
- sterile-barrier-failure
- microbial-contamination
- bacteremia
- sepsis
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)
- UDI-DI: N/A
Distribution
Distributed nationwide across the United States.
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