Recall Z-1791-2020— Argon Medical Devices, Inc

Name: FDA recall Z-1791-2020
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)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. 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)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. 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.