Device product
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter
Z-0877-2015
Product summary
- Firm
- PEROUSE MEDICAL
- Event
- Event 69879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2184 units
- Official record key
device-enforcement:Z-0877-2015
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: Batch numbers: 4041354/4062650/4072586
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