FDAFDA · Food and drugs·Recall number Z-2678-2026
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Published July 22, 2026 · Recall initiated: June 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Oscor Inc.
- Distributor
- Distribution in the US state of MA
- Lot
- All Lots within Expiry/GTIN:00885672009793, 00813502010664
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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