Argon Medical Devices, Inc: Medical Device Recall in 2020 - (Recall #: Z-1792-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.
Product Description:

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

Product Classification:

Class I

Date Initiated: December 4, 2019
Date Posted: May 13, 2020
Recall Number: Z-1792-2020
Event ID: 85398
Reason for Recall:

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

Status: Terminated
Product Quantity: 1190 units
Code Information:

Guidewire Model 114135150; LOT numbers: 11248718, 11251204, 11260495. 11268741, 11242667, 11241250 and 11239540

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated