Device product
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Z-1938-2026
Product summary
- Event
- Event 98649
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-1938-2026
Official wording
Reason: The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Code information: UDI/DI 00816734021699, Lot Numbers: 005983
Distribution pattern: US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
Derived failure modes
-
Unknown
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.