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.

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