medical Class I Updated 2020-05-13

Argon Medical Devices, Inc recalls 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
Lot/Code Info: Guidewire Model 114135150; LOT numbers: 11248718, 11251204, 11260495. 11268741, 11242667, 11241250 and 11239540
View official government recall

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