Diversatek Viper Wire Guided Balloon Dilator Inflation Tag Incorrect
Diversatek Healthcare is recalling Viper 3-Stage Wire Guided Balloon Dilators because the attached 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 for a medical device with incorrect critical labeling information (balloon diameters and inflation pressures) that could lead to device misuse and patient harm if the labeling error is not caught. The source text does not report any illnesses or injuries, so the harm is potential rather than realized.
Plain-English summary
Diversatek Healthcare is recalling the Viper 3-Stage Wire Guided Balloon Dilator, model 18mm-19mm-20mm (REF 1205-20). The catheter inflation tag attached to the device may contain an incorrect part number that lists incorrect balloon diameter sizes and inflation pressures for each stage.
Approximately 1,383 units have been distributed across multiple U.S. states (Missouri, California, Florida, Texas, Arizona, Pennsylvania, Rhode Island, North Carolina, Illinois, Mississippi, Kansas, New York, Ohio, Virginia, Louisiana, Iowa, Michigan, New Jersey, and Alabama), as well as Brazil and Belgium. The affected units are identified by UDI/DI 00816734021804 and the following lot numbers: 004947, 004950, 005311, 005397, 005484, and 005574.
Patients and healthcare providers should verify the actual device specifications and consult Diversatek Healthcare or the device instructions before using the product. Medical device users who have units with the affected lot numbers should contact Diversatek Healthcare immediately for guidance.
The recalled product
- Product
- Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
- Manufacturer
- Diversatek Healthcare
- Affected units
- 1,383
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 (7)
- UDI/DI 00816734021804
- Lot Numbers: 004947
- 004950
- 005311
- 005397
- 005484
- 005574
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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