Device product
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Z-1384-2018
Product summary
- Event
- Event 79646
- Status
- Terminated
- Classification
- Class II
- Quantity
- 655
- Official record key
device-enforcement:Z-1384-2018
Official wording
Reason: The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Code information: 0684 00 0294 01U and 0684 00 0294 02U
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.