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

FDA device recall Z-1938-2026 · posted 2026-04-23 · Open, Classified

Recall details

Recalling firm

Diversatek Healthcare

Reason for recall

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.

Action taken

Diversatek Healthcare issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 3/18/2026 via USPS. The notice explained the problem, risk to health, and requested the consignee discard any affected product. Complete and return the attached MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form and provide Signature Confirming Customer Receipt to Laura Boll, VP Regulatory Affairs & Quality at lboll@diversatek.com or 414-755-4806 to receive a replacement order. For questions about this issue, please contact Laura Boll, Vice President - Regulatory Affairs & Quality, at 414-755-4806 or lboll@diversatek.com.

Root cause

Labeling Change Control

Status

Open, Classified

Product code

KNQ

Quantity affected

15 units

Distribution

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

Date initiated

2026-03-18

Date posted

2026-04-23

Location

Milwaukee, WI