fda_recall · device_recall · high
Diversatek Healthcare — Class II recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18…
- Event date
- 2026-04-29 00:00:00Z
- Observed
- 2026-07-09 22:52:59Z
- Source ID
- Z-1940-2026
- Payload hash
- 0c1c2490af1be071f55706c0…
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.

