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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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.
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