ViperRecalls & reported problems across all models
Diversatek Healthcare, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name at least one Viper model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 4
We found 4 models of Viper by Diversatek Healthcare, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
4 FDA recall records name at least one of these models by its device identifier, 4 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Viper recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 18, 2026Class IIOpen, Classified
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.
Z-1941-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- Mar 18, 2026Class IIOpen, Classified
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.
Z-1940-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- Mar 18, 2026Class IIOpen, Classified
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.
Z-1939-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- Mar 18, 2026Class IIOpen, Classified
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.
Z-1938-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Viper models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Viper 1204-08Dilator, Esophageal1 recall0 reports
- Viper 1205-15Dilator, Esophageal1 recall0 reports
- Viper 1205-18Dilator, Esophageal1 recall0 reports
- Viper 1205-20Dilator, Esophageal1 recall0 reports
Other Diversatek Healthcare, Inc. products
All Diversatek Healthcare, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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