Abiomed Impella Introducer Kit Recalled Due to Potential Leakage
Oscor Inc. is recalling Abiomed REF: 0052-3025 Introducer Kits for Impella heart pump due to potential leakage from the sidearm and hub region. Manufacturing issues may cause the 14Fr and 23Fr introducer sheaths to leak under the sheath cap and along hub score lines.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified by the FDA as Class I and involves a medical device used in critical cardiac support. Class I recalls are defined as situations in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death. The potential for fluid leakage in an introducer sheath used with a heart pump represents a significant risk of harm during medical procedures.
Plain-English summary
Oscor Inc. is recalling the Abiomed REF: 0052-3025 Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport (14F 13cm and 25cm) used with the Impella heart pump and accessories. A total of 355 units have been distributed in Massachusetts.
Due to manufacturing issues, the 14Fr and 23Fr introducer sheaths have a potential to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. This leakage could compromise the proper function of the device during medical use.
Patients who have received this device or healthcare providers who have this product in stock should contact Oscor Inc. for instructions on device replacement or return. Healthcare facilities should verify the lot numbers and expiration dates against the affected GTINs: 00885672009793 and 00813502010664.
The recalled product
- Product
- Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
- Manufacturer
- Oscor Inc.
- Hazard
- device-leakage
- manufacturing-defect
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 (2)
- All Lots within Expiry/GTIN:00885672009793
- 00813502010664
Distribution
Distributed in 1 state:
- MA
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