FDA Enforcement
Class II
Ongoing
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Recall: Z-1938-2026
·
Reported April 29, 2026
Enforcement
- Recall Number
- Z-1938-2026
- Event ID
- 98649
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Diversatek Healthcare
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 29, 2026
- Initiation Date
- March 18, 2026
- Classification Date
- April 23, 2026
- Address
- 102 E Keefe Ave, N/A, Milwaukee, WI, 53212-1535, United States
Description
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
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.
Code Info
UDI/DI 00816734021699, Lot Numbers: 005983
Distribution
US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
Quantity
15 units