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Terminated

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

FDA Recall Z-1791-2020 · Posted 2020-05-07

Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeDQX
Date Initiated2019-12-04
Date Terminated2024-04-01
Product Quantity1690 units

Reason for Recall

The stiffness of the soft end of the guidewire caused tissue perforation.

Firm 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.

Root Cause

Employee error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160785Worker GuidewireArgon Medical Devices, Inc. · 2016-12-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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