Argon Medical Devices Recalls 0.035 Inch Guidewires Due to Tissue Perforation
Argon Medical Devices is recalling specific 0.035-inch guidewires because the stiffness of the soft end caused tissue perforation. The affected units were distributed to several countries outside the United States.
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 recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The source text explicitly states that the defect caused tissue perforation, which is a significant injury.
Plain-English summary
Argon Medical Devices, Inc. is recalling 1,690 units of 0.035"(.89mm)x80 cm guidewires, Model 114135080. The recall is due to a defect where the stiffness of the soft end of the guidewire caused tissue perforation. The affected product is identified by REF/UDI 114135080/(01)208863333008067 and includes LOT numbers 11235895, 11234476, 11237014, and 11240602.
The recalled guidewires were distributed to consignees in Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, and England. There are no US consignees listed for this recall. The product is labeled as RxOnly and STERILE EO.
Healthcare providers and patients should check their inventory and records for the specific model and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
- Manufacturer
- Argon Medical Devices, Inc
- Hazard
- Affected units
- 1,690
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 (5)
- Guidewire Model 114135080
- LOT numbers: 11235895
- 11234476
- 11237014
- and 11240602.
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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