Z-1277-2023 Class II Ongoing
FDA device recall Z-1277-2023 was initiated by Datascope Corp. on February 28, 2023 and is designated Class II. Reason for recall: There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety… The recall status is ongoing. Affected quantity: 391 total IABPs.
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2023
- Initiation Date
- February 28, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 391 total IABPs
Product Description
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Reason for Recall
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Distribution Pattern
Distribution list not yet provided.
Code Information
Model Number: 0998-00-0800-75, UDI-DI: 10607567112312; Model Number: 0998-00-0800-83, UDI-DI: 10607567108407; Model Number: 0998-00-0800-85, UDI-DI: 10607567113449; Serial Numbers: CA237026J3 CH231276C6