fda_recall · device_recall · high

Diversatek Healthcare — Class II recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm…

Event date
2026-04-29 00:00:00Z
Observed
2026-07-09 22:53:00Z
Source ID
Z-1941-2026
Payload hash
058e2ed7452b77a977c66dd9

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.

Informational only. Not legal, financial, or medical advice.