Abiomed Introducer Kit Sterile Barrier Compromise Risks Infection
Abiomed introducer kits may have holes in the outer pouch, compromising sterility and exposing patients to potential microbial contamination. This could lead to serious infections including bacteremia or sepsis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall of a medical device with potential for serious patient harm (infection, bacteremia, sepsis) from sterile barrier compromise. No illnesses or injuries have been reported; the hazard is theoretical based on risk exposure, placing this at the upper boundary of High per the rubric criteria.
Plain-English summary
Abiomed, Inc. is recalling the Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (Part Number 0052-3052). The Introducer Kit is intended for introduction of the Impella Catheter into the body. This recall affects 1,784 single units distributed nationwide and internationally.
Holes in the outer pouch of the Introducer Kits (both trayed and non-trayed versions) may compromise the sterile barrier. When non-sterile, the product exposes patients to the possibility of introducing micro-organisms into the vasculature and/or access site, which could result in an infectious process, bacteremia, or sepsis.
The recalled product
- Product
- Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052
- Manufacturer
- Abiomed, Inc.
- Affected units
- 1,784
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
Part of a larger recall action
This product is one of 10 recalled by Abiomed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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