FDA Medical Device Recalls (openFDA)
Uromedica Inc.: ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
- Recall number
- Z-1808-2020
- Recalling firm
- Uromedica Inc.
- Product
- ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
- Status
- Terminated
- Initiated
- 2019-04-10
- Posted
- not on file
- Terminated
- 2020-05-18
- Reason
- Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.
- Root cause
- Nonconforming Material/Component
- Action
- Uromedica sent a notification to the customers via email and letter instructing them to identify the affected sets and returned them to Uromedica within 10 business days. Uromedica will provide for the return shipping of the affected tool set and replace if free of charge.
- Quantity
- 11 tool sets
- Distribution
- Nationwide distribution to the following states: CA, GA, FL, MI, and VA.
- Lot, serial or model codes
- Model 750041, Lot # UM00650
- 510(k) numbers
- not on file
- PMA numbers
- ["P130018"]
- Product code
- KOA
- Firm FEI
- 3003477176
- Firm city
- Plymouth
- Firm state
- MN
- 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