Medical Device Recall: Abiomed Axillary Insertion Introducer Sterile Barrier Breach
Abiomed Axillary Insertion Introducer Kits have holes in the outer pouch that may compromise sterility, potentially exposing patients to serious infections including bacteremia and sepsis.
What this means for you
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 of a cardiac medical device where sterile barrier compromise poses a clear risk of serious infection (bacteremia or sepsis) in patients, but no illnesses or injuries are reported in the source. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abiomed, Inc. has recalled the Axillary Insertion Introducer Kits (Part Number 0052-3006), which are medical devices used to insert Impella Catheters during cardiac procedures. The recall affects 717 single units and 1,906 units within pump sets, distributed nationwide and internationally across multiple countries.
The recall was issued because holes have been identified in the outer pouch of some Introducer Kits. These holes compromise the sterile barrier that protects the device. When the sterile barrier is compromised, non-sterile devices can expose patients to the introduction of microorganisms into the bloodstream and access sites, potentially leading to infection, bacteremia, or sepsis.
Patients and healthcare providers who have received or used any of these introducers should contact Abiomed, Inc. immediately and not use any affected devices. Follow the manufacturer's instructions for proper handling and return of the recalled products.
The recalled product
- Product
- Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)
- Manufacturer
- Abiomed, Inc.
- Hazard
- sterility-breach
- infection-risk
- sepsis
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: 00885672009755
Distribution
Distributed nationwide across the United States.
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