The Recall Desk
SevereFDA (Devices)·Z-1792-2020·Announced 2020-05-13

Argon Medical Devices Recalls 0.035 Inch Guidewires Due to Tissue Perforation Risk

Argon Medical Devices is recalling specific 0.035-inch guidewires because the soft tip stiffness caused tissue perforation. The affected units were distributed to several countries outside the US.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that the defect 'caused tissue perforation,' which constitutes a significant injury report. Per the rubric, significant injury reports warrant a score of 4 (Severe).

Plain-English summary

Argon Medical Devices, Inc. is recalling 1,190 units of 0.035-inch (.89mm) x 150 cm guidewires, Model 114135150. The recall is due to a defect where the stiffness of the soft end of the guidewire caused tissue perforation.

The affected products are identified by the following lot numbers: 11248718, 11251204, 11260495, 11268741, 11242667, 11241250, and 11239540. The Reference/UDI is 114135150/(01)20886333008074. These devices are prescription-only and sterile.

There were no US consignees for this recall. The products were distributed to consignees in Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, and England. Healthcare providers and patients should stop using these specific guidewires and contact the manufacturer for further instructions.

The recalled product

Product
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Interventional Cardiology
Hazard
Affected units
1,190

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Guidewire Model 114135150
  • LOT numbers: 11248718
  • 11251204
  • 11260495. 11268741
  • 11242667
  • 11241250 and 11239540

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Argon Medical Devices, Inc

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Same hazard · tissue perforation

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