Argon Medical Devices, Inc: Medical Device Recall in 2020 - (Recall #: Z-1791-2020)

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)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO

Product Classification:

Class I

Date Initiated: December 4, 2019

Date Posted: May 13, 2020

Recall Number: Z-1791-2020

Event ID: 85398

Reason for Recall:

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

Status: Terminated

Product Quantity: 1690 units

Code Information:

Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated