FDA DeviceClass IINotable

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

Date: 2026-04-29
Brand: Diversatek Healthcare
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

527 units

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