Recall Z-1792-2020— Argon Medical Devices, Inc

Name: FDA recall Z-1792-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-04

Class I · Terminated

Class I FDA medical device recall by Argon Medical Devices, Inc, initiated 2019-12-04, terminated 2024-04-01. It names one FDA 510(k) clearance: K160785. Product: 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO. Reason: The stiffness of the soft end of the guidewire caused tissue perforation..

Recalling firm: Argon Medical Devices, Inc
Classification: Class I
Status: Terminated
Initiated: 2019-12-04
Terminated: 2024-04-01
Firm location: Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K160785 — Worker GuidewireArgon Medical Devices, Inc.·cleared 2016-12-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.