FDA DevicesClass II
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm...
Published: April 29, 2026Recall ID: Z-1941-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
Additional Source Details
| Field | Value |
|---|---|
| City | Milwaukee |
| State | WI |
| Event id | 98649 |
| Address 1 | 102 E Keefe Ave |
| Address 2 | N/A |
| Code info | UDI/DI 00816734021804, Lot Numbers: 004947, 004950, 005311, 005397, 005484, 005574 |
| Postal code | 53212-1535 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 1383 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260318 |
| Initial firm notification | Letter |
| Center classification date | 20260423 |
Overview
- Recalling FirmDiversatek Healthcare
- StatusOngoing
- Risk LevelClass II
- DistributionUS: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium