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

Medical DevicesSource: FDA (device) · Date: 2026-04-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Diversatek Healthcare
Product
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
Recall initiated
2026-03-18
Code info
UDI/DI 00816734021781, Lot Numbers: 004758, 005124, 005309, 005629
Product quantity
527 units
Voluntary mandated
Voluntary: Firm initiated
City
Milwaukee
State
WI
Country
United States
Event id
98649
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