Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. Recalled by Argon Medical Devices, Inc Due to The stiffness of the soft end of the...

Date: December 4, 2019
Company: Argon Medical Devices, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Argon Medical Devices, Inc directly.

Affected Products

0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO

Quantity: 1190 units

Why Was This Recalled?

The stiffness of the soft end of the guidewire caused tissue perforation.

Where Was This Sold?

No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England

About Argon Medical Devices, Inc

Argon Medical Devices, Inc has 42 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report