# FDA recall Z-1791-2020

> **Argon Medical Devices, Inc** · Class I · device recall initiated 2019-12-04.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1791-2020
- **Recalling firm:** Argon Medical Devices, Inc
- **Classification:** Class I
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1791-2020

## Citation

> AI Analytics. FDA recall Z-1791-2020. Retrieved 2026-06-22 from https://api.ai-analytics.org/recall/Z-1791-2020. Source: US FDA. Licensed CC0.

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