Abiomed Introducer Kits recalled due to sterile barrier compromise
Abiomed is recalling Introducer Kits because holes in the outer pouch may compromise the sterile barrier, risking bacterial infection. The kits are distributed nationwide and internationally.
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 a Class II medical device recall with no reported illnesses or injuries to date. The hazard—sterile barrier compromise leading to potential infection and sepsis—represents a risk of harm, but no actual injuries have been reported, placing this in the High severity category.
Plain-English summary
Abiomed, Inc. is recalling the KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (Part Number 0052-3056). These introducer kits are used to introduce the Impella Catheter into the body.
Holes have been discovered in the outer pouch of the introducer kits, affecting both trayed and non-trayed versions. These holes may compromise the sterile barrier of the kit. A non-sterile product exposes patients to the possibility of microbial contamination in the vasculature and at the access site, which could lead to infection, bacteremia, or sepsis.
The affected kits have been distributed nationwide in the United States as well as internationally.
No illnesses or injuries related to this recall have been reported to date.
The recalled product
- Product
- Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056
- Manufacturer
- Abiomed, Inc.
- Affected units
- 2
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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