Abiomed Oscor Introducer Kit Recalled Due to Sterile Barrier Compromise
Abiomed is recalling its Oscor Introducer Kit due to holes in the outer pouch that may compromise the sterile barrier. Non-sterile introducers could expose patients to infection, 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 for a sterile barrier defect with potential for serious harm (infection, bacteremia, sepsis), where no injuries have yet been reported. The hazard is theoretical, based on the defect mechanism.
Plain-English summary
Abiomed, Inc. is recalling the Oscor Introducer Kit, 14Fr x Short (Part 0052-3014), a medical device used to introduce the Impella Catheter into the body. Both trayed and non-trayed versions are included in this recall, with distribution nationwide and in several countries.
The recalled kits may contain holes in the outer pouch. These holes can compromise the sterile barrier of the introducer, potentially allowing micro-organisms to reach the patient's vasculature or access site. This could result in infection, bacteremia, or sepsis.
This is classified as an FDA Class II recall.
The recalled product
- Product
- Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Vascular Access
- Affected units
- 4
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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