Diversatek Healthcare Viper¿ 3-Stage Wire Guided recall
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
Why was Diversatek Healthcare Viper¿ 3-Stage Wire Guided recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00816734021798, Lot Numbers: 005985
- Product
- Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
- Recalling firm
- Diversatek Healthcare
- Quantity
- 250 units
- Distribution
- US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
- Recall date
- April 29, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)