fda_recall · device_recall · high
Diversatek Healthcare — Class II recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15…
- Event date
- 2026-04-29 00:00:00Z
- Observed
- 2026-07-09 22:53:00Z
- Source ID
- Z-1939-2026
- Payload hash
- 68ec67eff5b621a6febb9955…
Summary
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. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.