FDAHealthMarch 18, 2026

Diversatek Healthcare — Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08

⚠️ 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.

Is this relevant to me?

Geography: US, MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL
Source agency: FDA
Category: Health
Published: March 18, 2026

US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium

What's affected?

Product: Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
Brand: Diversatek Healthcare
Lot code: 005983

Additional details

UDI/DI 00816734021699, Lot Numbers: 005983

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 15 units.

View original FDA notice →

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