FDA Device recall Z-1791-2020
0.035"(.89mm)x80 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)x80 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-1791-2020 |
| 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)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Reason
The stiffness of the soft end of the guidewire caused tissue perforation.
Identifiers
| code_info | Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Argon Medical Devices
- L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - General Biospy Tray, REF: GUTS1000
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - Arterial Line Kit 20ga x 6, REF: 400115A
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
FDA Device · Class I · 2026-07-22 · Argon Medical Devices
All Argon Medical Devices recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1791-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.