Oscor Intro Catheter Introducer Kit: Compromised Sterile Barrier
Abiomed is recalling Oscor Intro Introducer Kits due to holes in the outer pouch that may compromise the sterile barrier, potentially exposing patients to harmful bacteria and 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: FDA Class II medical device with potential for serious infection (bacteremia, sepsis) resulting from sterile barrier compromise. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3 (High).
Plain-English summary
Abiomed, Inc. is recalling the Oscor Intro Catheter Introducer Kit (Part Number 0052-3025), which is used to guide the Impella Catheter into blood vessels during heart procedures. The kits are available in both trayed and non-trayed versions and have been distributed nationwide and internationally.
The recall was initiated because holes have been found in the outer protective pouch of the Introducer Kits. These holes can compromise the sterile barrier that keeps the product free from bacteria and other harmful micro-organisms. If the sterile barrier is breached, patients are at risk of microbial contamination.
When a sterile product is contaminated with bacteria or other micro-organisms, it can cause serious infections. Specifically, contamination introduced into blood vessels or the access site could lead to bacteremia (infection in the bloodstream) or sepsis (a severe, potentially life-threatening infection).
Patients and healthcare providers with Oscor Intro Introducer Kits should contact their healthcare provider or Abiomed for guidance. Healthcare facilities should check inventory for affected units and follow the manufacturer's instructions for return, replacement, or further management.
The recalled product
- Product
- Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
- Manufacturer
- Abiomed, Inc.
- Hazard
- sterile-barrier-compromise
- bacteremia
- 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: N/A
Distribution
Distributed nationwide across the United States.
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