Z-1791-2020Class I

0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067...

Name: Z-1791-2020 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067...
Creator: Argon Medical Devices, Inc
Published: 2019-12-04
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2019-12-04 / Terminated / root cause: manufacturing process

FDA source

Argon Medical Devices, Inc began a recall of 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO on 2019-12-04. FDA classified it as Class I and gives the reason as "The stiffness of the soft end of the guidewire caused tissue perforation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1791-2020
Classification: Class I
Status: Terminated
Initiated: 2019-12-04
Posted: 2020-05-07
Terminated: 2024-04-01
Recalling firm: Argon Medical Devices, Inc
Product: 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Product code: DQX Wire, Guide, Catheter
Reason for recall: The stiffness of the soft end of the guidewire caused tissue perforation.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On 12/04/2019, the firm sent Medical Device Recall letter by email to their customer/ distributors. Customers are instructed to inspect and quarantine and return any affected product remaining at their facility utilizing the instruction on the Recall Response Form. Customers are instructed to complete the response acknowledgement form included with the letter and return by fax, mail or email as soon as possible. Customers were also instructed to pass the notice on to all those who need to be aware within their organization or to any organization to which the potentially affected devices have been transferred.
Quantity in commerce: 1690 units
Distribution: No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
Product codes and lots: Guidewire Model 114135080; LOT numbers: 11235895, 11234476, 11237014, and 11240602.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1791-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1791-2020	Class I	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-07
Z-1792-2020	Class I	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-07

Product code DQX

K160785Class IIWorker GuidewireArgon Medical Devices, Inc. / cleared 2016-12-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)