Abiomed Impella Introducer Kit recalled for potential fluid leakage
Oscor Inc. is recalling the Abiomed Impella Hemostatic Peel Away Introducer System (23F) due to manufacturing defects that may cause leakage from the sidearm, under the sheath cap, or along the hub region.
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 source material identifies this as an FDA Class I recall. Per the rubric, FDA Class I recalls receive a minimum severity score of 4 (Severe).
Plain-English summary
Oscor Inc. is recalling the Abiomed REF 0052-3006 Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F, a heart pump accessory. The recall affects 32,934 units distributed in Massachusetts.
The product may leak fluid from the sidearm, under the sheath cap, and along the hub score lines in the hub region due to manufacturing issues. These potential leaks could compromise the device's function during use.
Patients and healthcare providers who have this product should contact their medical center or Oscor Inc. for guidance on next steps. The recall includes all lots within the expiry date matching GTIN 00885672009755 or 00813502011609.
The recalled product
- Product
- Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
- Manufacturer
- Oscor Inc.
- Affected units
- 32,934
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:00885672009755/00813502011609
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.
See all 3 products in this recall →Related recalls
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