0 — Class I medical device recall Z-1791-2020
Terminated recall by Argon Medical Devices, Inc, reported 2020-05-13. The stiffness of the soft end of the guidewire caused tissue perforation.
| Recall number | Z-1791-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2019-12-04 |
| Classified | 2020-05-07 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2024-04-01 |
| Countries outside the US | DK, GB, GR, HK, NO, SE, SI, TR |
| Quantity | 1,690 units |
| Lot numbers | 11234476, 11235895, 11237014, 11240602 |
| Model numbers | 114135080 |
Product
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Reason for recall
The stiffness of the soft end of the guidewire caused tissue perforation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1791-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.