0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip… recallZ-1792-2020 · Argon Medical Devices, Inc · initiated Dec 4, 2019
Class I Terminated All recalls posted in May 2020
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Argon Medical Devices, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The stiffness of the soft end of the guidewire caused tissue perforation.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1792-2020
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Dec 4, 2019
- Posted by the FDA
- May 7, 2020
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 1190 units
- Product code
- DQX
- FDA submissions
- K160785
- Distribution
- No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
Product description
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
Code information (models, lots, serial numbers)
Guidewire Model 114135150; LOT numbers: 11248718, 11251204, 11260495. 11268741, 11242667, 11241250 and 11239540
Other devices under the same FDA submission
1 device cleared under K160785 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Worker™ Guidewire 110135080Argon Medical Devices, Inc. · Wire, Guide, Catheter3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 85398).
- Z-1791-2020 · Terminated0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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