Device product
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
Z-0876-2015
Product summary
- Firm
- PEROUSE MEDICAL
- Event
- Event 69879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24821 units
- Official record key
device-enforcement:Z-0876-2015
Official wording
Reason: Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Code information: All lot numbers beginning with Numbers: 1403,1404,1405,1406,1407
Distribution pattern: US Nationwide Distribution in the states of AZ and CO.
Derived failure modes
-
Unknown
Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure