Argon Medical Devices recalls specific guidewire models due to soft tip stiffness causing tissue perforation. Affected units include model 114135080 with lot numbers 11235895, 11234476, 11237014, and 11240602. Contact for remedy details.
The stiffness of the soft end of the guidewire caused tissue perforation.
Argon Medical Devices is recalling a specific guidewire model because its soft tip can be too stiff, potentially causing tissue perforation. This is a serious risk for medical procedures where the guidewire is used.
The guidewire's soft tip is too stiff, which can cause it to puncture or tear tissue during medical procedures. This risk is particularly concerning in delicate procedures where precise guidance is needed.
Healthcare professionals using this guidewire during medical procedures are most at risk. Patients receiving procedures with this specific guidewire model could experience tissue damage.
Check for model number 114135080 with lot numbers 11235895, 11234476, 11237014, or 11240602. The product is a sterile guidewire sold only by prescription.
Immediately stop using the guidewire if it has the model number 114135080 and one of the listed lot numbers.
No, the soft tip stiffness can cause tissue perforation, so it should not be used.
The recall record does not specify a remedy, so contact Argon Medical Devices for instructions.
Lot numbers 11235895, 11234476, 11237014, and 11240602 are affected.
We’ve drafted a message you can send Argon Medical Devices to request your refund or repair — edit it as you like.
Subject: Recall Z-1791-2020 — Argon Medical Devices Argon Medical Devices Hello, I own a Argon Medical Devices that is covered by recall Z-1791-2020 from Argon Medical Devices. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
