FDA Medical Device Recalls (openFDA)
Argon Medical Devices, Inc: 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
- Recall number
- Z-1792-2020
- Recalling firm
- Argon Medical Devices, Inc
- Product
- 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
- Status
- Terminated
- Initiated
- 2019-12-04
- Posted
- 2020-05-07
- Terminated
- 2024-04-01
- Reason
- The stiffness of the soft end of the guidewire caused tissue perforation.
- Root cause
- Employee error
- Action
- On 12/04/2019, the firm sent Medical Device Recall letter by email to their customer/ distributors. Customers are instructed to inspect and quarantine and return any affected product remaining at their facility utilizing the instruction on the Recall Response Form. Customers are instructed to complete the response acknowledgement form included with the letter and return by fax, mail or email as soon as possible. Customers were also instructed to pass the notice on to all those who need to be aware within their organization or to any organization to which the potentially affected devices have been transferred.
- Quantity
- 1190 units
- Distribution
- No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
- Lot, serial or model codes
- Guidewire Model 114135150; LOT numbers: 11248718, 11251204, 11260495. 11268741, 11242667, 11241250 and 11239540
- 510(k) numbers
- ["K160785"]
- PMA numbers
- not on file
- Product code
- DQX
- Firm FEI
- 1625425
- Firm city
- Athens
- Firm state
- TX
- 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