Abiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk
Oscor Inc. is recalling Abiomed introducer kits due to manufacturing issues that may cause the 14Fr and 23Fr introducer sheaths to leak. The recall affects approximately 1,332 units distributed in Massachusetts.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall, which per the rubric mandates a minimum score of 4. This is a critical cardiovascular device (heart pump introducer kit) where potential leakage poses risk of harm during use.
Plain-English summary
Oscor Inc. is recalling the Abiomed REF: 0052-3021 Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport (14F and 23F sizes) due to manufacturing issues.
The introducer sheaths may leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. This potential for leakage could compromise the device's function during use.
Approximately 1,332 units were distributed in Massachusetts. The recall affects all lots within expiry (GTIN: 00885672009786 and 00813502010558).
Patients and healthcare providers who have this device should contact Oscor Inc. for instructions on replacement or appropriate corrective action.
The recalled product
- Product
- Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
- Manufacturer
- Oscor Inc.
- Affected units
- 1,332
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)
- All Lots within Expiry/GTIN:00885672009786/00813502010558
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Oscor 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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