Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator recall (Diversatek Healthcare)
Medical deviceClass IIOngoing
Summary: Diversatek Healthcare is recalling Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15. 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.
What is being recalled
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium (states named: Alabama, Arizona, California, Florida, Iowa, Illinois, Kansas, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas, Virginia)
How to tell if yours is affected
UDI/DI 00816734021781, Lot Numbers: 004758, 005124, 005309, 005629
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1939-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 18, 2026 |
| Reported | April 29, 2026 |
| Company | Diversatek Healthcare |
| Company location | Milwaukee, WI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 527 units |
More recalls from Diversatek Healthcare · all medical device recalls · recalls from March 2026