FDA Medical Device Recalls (openFDA)
Diversatek Healthcare: Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
- Recall number
- Z-1941-2026
- Recalling firm
- Diversatek Healthcare
- Product
- Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
- Status
- Open, Classified
- Initiated
- 2026-03-18
- Posted
- 2026-04-23
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Labeling Change Control
- Action
- 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.
- Quantity
- 1383 units
- Distribution
- US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium
- Lot, serial or model codes
- UDI/DI 00816734021804, Lot Numbers: 004947, 004950, 005311, 005397, 005484, 005574
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KNQ
- Firm FEI
- 2183446
- Firm city
- Milwaukee
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28