Abiomed Introducer Kit recalled due to sterile barrier compromise risk
Abiomed is recalling Introducer Kits (part 0052-3021) with holes in the outer pouch that compromise the sterile barrier, potentially exposing patients to infection. The kits were 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: FDA Class II medical device with potential for serious infections (bacteremia and sepsis) due to compromised sterile barrier. No reported illnesses or injuries stated in source; the hazard is potential rather than confirmed.
Plain-English summary
Abiomed, Inc. is recalling Introducer Kits, 23 Fr with Helix Valve (part number 0052-3021), intended for introduction of the Impella Catheter into the body. The recall covers 193 single units and 1,034 units distributed within kits. These products were distributed nationwide and in multiple countries.
Some units have holes in the outer pouch that compromise the sterile barrier. When the sterile barrier is compromised, the product may no longer be sterile, creating a risk of introducing microorganisms during clinical use.
Non-sterile product can introduce microorganisms into the vasculature and surgical access sites, potentially causing infections, bacteremia (microorganisms in the bloodstream), or sepsis (a serious infection response).
Healthcare facilities should immediately stop using affected kits and contact Abiomed for replacement products. Patients who underwent procedures with these kits should consult their healthcare provider if they develop signs of infection, including fever, chills, or other concerning symptoms.
The recalled product
- Product
- Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
- 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: 00885672009786
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.
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