Abiomed Introducer Kits Recalled for Sterile Barrier Pouch Defect
Abiomed is recalling 84 introducer kits that may have holes in the outer pouch, compromising the sterile barrier. This exposes patients to microbial contamination and risk of serious infections including bacteremia and 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. While bacteremia and sepsis are serious potential outcomes, the source text reports no illnesses or hospitalizations. The recall concerns a risk-of-harm product where no injury has yet been reported, fitting Score 3 per the rubric.
Plain-English summary
Abiomed is recalling 84 units of the 23Fr Introducer Kit (Part Number 2000342), a sterile medical device designed to introduce the Impella Catheter into the body. The kits have been distributed nationwide and to multiple countries.
Holes in the outer pouch of these introducer kits may compromise the sterile barrier. Non-sterile product exposes patients to the possibility of microbial contamination entering the vasculature or access site, which may lead to serious infectious processes such as bacteremia or sepsis.
Healthcare providers and patients who may have received affected kits should contact Abiomed for additional information and guidance regarding this recall. The kits are identifiable by Part Number 2000342.
The recalled product
- Product
- Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
- Manufacturer
- Abiomed, Inc.
- Hazard
- sterile-barrier-breach
- microbial-contamination
- bacteremia-risk
- sepsis-risk
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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