FDAHealthMarch 18, 2026

Diversatek Healthcare — Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15

⚠️ 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 Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
Brand: Diversatek Healthcare
Lot code: 004758

Additional details

UDI/DI 00816734021781, Lot Numbers: 004758, 005124, 005309, 005629

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 527 units.

View original FDA notice →

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