FDA Device Recall Z-0337-2022
Datascope Corp. · Mahwah, NJ
Class I — life-threatening Ongoing
Device
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
Reason for recall
Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability.
Recall record
- Recall number
Z-0337-2022- Classification
- Class I
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Worldwide distribution - US Nationwide.
- Recall initiated
- 2021-11-15
- Classified by FDA Center
- 2021-12-15
- FDA published
- 2021-12-22
- Recalling firm
- Datascope Corp.
- Firm location
- Mahwah, NJ
Operational response
A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.
For the official FDA enforcement record, see FDA's Recall Search.