Diversatek Viper Balloon Dilator
Diversatek recalls Viper 3-Stage Balloon Dilator (6-7-8mm) due to incorrect inflation tag info.
Consumers should immediately stop using the affected device and contact Diversatek Healthcare for instructions on returning the product or obtaining a replacement. If you have used this device on a patient, report any adverse events to the FDA's MedWatch program.
Why it was recalled
Diversatek Healthcare is recalling the Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08, because the catheter inflation tag may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. This could lead to improper dilation during procedures, potentially causing patient injury.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Diversatek Healthcare Viper¿ 3-Stage
| Product | Recall # | UDI-DI |
|---|---|---|
| Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18 | Z-1940-2026 | 00816734021798 |
| Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20 | Z-1941-2026 | 00816734021804 |
| Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15 | Z-1939-2026 | 00816734021781 |
| Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08 | Z-1938-2026 | 00816734021699 |
Where it was sold
Distributed in Alabama, Arizona, California, Florida, Iowa, Illinois, Kansas, Louisiana, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas, and Virginia.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification