FDA Device recall Z-1792-2020
0.035"(.89mm)x150 cm guidewire
- FDA Device
- Class I
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class I recall of 0.035"(.89mm)x150 cm guidewire by Argon Medical Devices, citing the stiffness of the soft end of the guidewire caused tissue perforation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1792-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-12-04 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Argon Medical Devices |
| Distribution | n/a |
Product
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
Reason
The stiffness of the soft end of the guidewire caused tissue perforation.
Identifiers
| code_info | Guidewire Model 114135150; LOT numbers: 11248718, 11251204, 11260495. 11268741, 11242667, 11241250 and 11239540 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1792-2020%22
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