Abiomed recall
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
Why was Abiomed recalled?
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots within Expiry/GTIN:00885672009755/00813502011609
- Product
- Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
- Recalling firm
- Oscor Inc.
- Quantity
- 32,934 units
- Distribution
- Distribution in the US state of MA
- Recall date
- July 22, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)