Recall Z-1940-2026— Diversatek Healthcare
Class II · Ongoing
Class II FDA medical device recall by Diversatek Healthcare, initiated 2026-03-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18. Reason: 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..
- Recalling firm
- Diversatek Healthcare
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-18
- Firm location
- Milwaukee, WI, United States
Product description
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.