Device product
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
Z-1939-2026
Product summary
- Event
- Event 98649
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 527 units
- Official record key
device-enforcement:Z-1939-2026
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 00816734021781, Lot Numbers: 004758, 005124, 005309, 005629
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.