Medtronic Cougar Nitinol Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling specific Cougar Nitinol Workhorse Guidewires because the PTFE coating may delaminate and detach from the device.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Medtronic Vascular is recalling approximately 10,230 units of Cougar Nitinol Workhorse Guidewires. The recall involves specific models including CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S, CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, and CGRXT300S. These steerable guide wires are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature.
The recall is due to a potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the guidewire. The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries such as Canada, the United Kingdom, Germany, and Japan.
Healthcare providers and consumers should stop using the affected guidewires and contact Medtronic Vascular for further instructions. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the introduction
- Manufacturer
- Medtronic Vascular
- Affected units
- 10,230
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medtronic Vascular 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 8 products in this recall →Related recalls
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