FDAFDA · Food and drugs·Recall number Z-2615-2021
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Published October 6, 2021 · Recall initiated: September 8, 2021
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
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Datascope Corp.
- Distributor
- Nationwide domestic distribution. Foreign distribution worldwide.
- Lot
- All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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