Abiomed Introducer Kit Recalled for Compromised Sterile Barrier
Abiomed is recalling introducer kits due to holes in the outer pouch that compromise the sterile barrier. Non-sterile product could allow microbial contamination, leading to infection such as 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: This FDA Class II recall involves a sterile medical device with a design defect (holes compromising the sterile barrier) that enables serious infection risk (bacteremia, sepsis) through vascular access contamination. Per the severity rubric, high-risk pathogens and risk-of-harm products where injury has not yet been reported are classified as High. No hospitalizations or reported illnesses are documented in the source.
Plain-English summary
Abiomed, Inc. is recalling its 14Fr Introducer Kit (Part Numbers 0052-0039 and 0052-0053), sterile components intended for introduction of the Impella Catheter into the body during cardiac support procedures. The kits are available in both trayed and non-trayed configurations.
The recalled kits contain holes in the outer pouch that compromise the sterile barrier. This barrier protects the device from microbial contamination before use.
When the sterile barrier is compromised, the product may no longer be sterile. Non-sterile Introducer Kits expose patients to the risk of microbial contamination during insertion into the body. This contamination could allow microorganisms to reach the vasculature and access site, potentially leading to serious infections including bacteremia and sepsis.
The product was distributed nationwide and internationally to multiple countries. Healthcare providers should be aware of this recall.
The recalled product
- Product
- Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053
- Manufacturer
- Abiomed, Inc.
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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