FDAFDA · Food and drugs·Recall number Z-2319-2024
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Published July 24, 2024 · Recall initiated: May 31, 2024
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
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Abiomed, Inc.
- Distributor
- Domestic only: FL, MA, OH TX.
- Lot
- Product No.: 1000080 (REF 0048-0003); UDI/DI: 00813502012279; Lot/Serial No.: Lot 1798046; Serial numbers: 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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