Abiomed Oscor Introducer Kit sterile barrier holes risk infection
Abiomed Oscor Introducer Kits may have holes in the outer pouch that compromise sterility. This could allow bacteria to enter the patient's bloodstream during catheter insertion.
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 is an FDA Class II recall with a potential high-risk hazard (bacteremia or sepsis through compromised sterile barrier). However, no illnesses or injuries are reported in the source text. Per the rubric, when reported harm is absent and the hazard is theoretical, the score is at most 3.
Plain-English summary
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (Part Number 0052-3015) is being recalled. This device is used to introduce the Impella Catheter into the body for cardiac support. Three single units are affected by this recall.
The recalled Introducer Kits may have holes in the outer pouch—whether the kits are trayed or non-trayed—that compromise the sterile barrier. A compromised sterile barrier means the product is not sterile before use.
When patients receive a non-sterile Introducer Kit during catheter insertion, bacteria and other microorganisms can be introduced into the bloodstream and vascular access site, potentially causing infection, bacteremia, or sepsis.
The recalled product
- Product
- Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015
- Manufacturer
- Abiomed, Inc.
- Affected units
- 3
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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