Official recall notice
FDA DeviceClass IINotable
FDA Recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
- Recall date
- 2026-04-29
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Recommended action
What to do
250 units
Product description
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.