Diversatek Healthcare Viper Balloon Dilator catheter inflation tag error
Diversatek Healthcare is recalling Viper 3-Stage Wire Guided Balloon Dilators because the catheter inflation tag may contain an incorrect part number with wrong balloon diameter sizes and inflation pressures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a medical device with a labeling/instruction defect that could lead to improper use and patient harm. No reported illnesses or injuries are stated in the source, but the risk-of-harm nature of an interventional catheter with incorrect pressure information justifies a High severity rating.
Plain-English summary
Diversatek Healthcare is recalling the Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm (REF 1205-15) due to an issue with the catheter inflation tag. The tag may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Approximately 527 units have been distributed across the United States, Brazil, and Belgium. The affected lot numbers are 004758, 005124, 005309, and 005629 (UDI/DI 00816734021781).
Healthcare providers and facilities that have this device should contact Diversatek Healthcare for instructions regarding the incorrect inflation tag and verify the correct specifications before use. Using the device with incorrect inflation pressure information could result in improper balloon expansion during the procedure.
The recalled product
- Product
- Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
- Manufacturer
- Diversatek Healthcare
- Affected units
- 527
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI/DI 00816734021781
- Lot Numbers: 004758
- 005124
- 005309
- 005629
Distribution
Part of a larger recall action
This product is one of 4 recalled by Diversatek Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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