Argon Medical Devices Recalls Soft Tip Guidewire Due to Tissue Perforation Risk
Argon Medical Devices recalls specific soft tip guidewires (Model 114135150) that may cause tissue perforation. Affected units include certain lot numbers from 2020-2021. Consumers should contact the company for details.
Use caution until it’s fixed
The stiffness of the soft end of the guidewire caused tissue perforation.
Contact the company
What happened, in plain English
Argon Medical Devices is recalling a specific soft tip guidewire model that may cause tissue perforation. This risk occurs due to the guidewire's stiffness at the soft end, which can damage tissue during medical procedures. Read more at govinfonow.com/recall/66402-argon-medical-devices-recalls-soft-tip-guidewire-due-to-tissue.
Source Summary by GovInfoNow · govinfonow.com/recall/66402-argon-medical-devices-recalls-soft-tip-guidewire-due-to-tissue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1792-2020
Cite this page
“Argon Medical Devices Recalls Soft Tip Guidewire Due to Tissue Perforation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66402-argon-medical-devices-recalls-soft-tip-guidewire-due-to-tissue. Based on FDA recall #Z-1792-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1792-2020%22&limit=1).
Why it’s dangerous
The guidewire's soft end is too stiff, which can cause tissue perforation during medical procedures. This risk is specific to the stiffness at the tip of the guidewire when used in procedures.
Who’s affected
Medical professionals using the guidewire for procedures are most at risk. Patients receiving the guidewire during medical procedures may also be affected.
How to tell if you have this one
Check for the model number 114135150 on the guidewire. Lot numbers include 11248718, 11251204, 11260495, 11268741, 11242667, 11241250, and 11239540.
- Brand
Argon Medical Devices- Product
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1791-2020 | 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO; Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602. | 1690 units |
| Z-1792-2020 | 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO; Guidewire Model 114135150; LOT numbers: 11248718, 11251204, 11260495. 11268741, 11242667, 11241250 and 11239540 | 1190 units |
What to do — step by step
Contact Manufacturer
Reach out to Argon Medical Devices for specific instructions on how to handle the recalled guidewire.
How this recall unfolded
Recall timeline
FDA terminated this recall 4.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How can I check if I have the recalled guidewire?
Look for the model number 114135150 and the listed lot numbers on the guidewire packaging or label.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1792-2020 (December 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1792-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.