FDA recall Z-1792-2020

Argon Medical Devices, Inc · Class I · device

Product

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-12-04
Report date
2020-05-13
Termination date
2024-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1792-2020