Medtronic Thunder Extra Support Guidewire Recalled for Coating Delamination Risk
Medtronic Vascular is recalling 58 Thunder Extra Support Guidewires because the PTFE coating may delaminate and detach from the device.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which the rubric defines as unlikely to cause adverse health consequences, typically corresponding to a score of 1 or 2. Given the potential for a physical defect in a medical device, a score of 2 is appropriate.
Plain-English summary
Medtronic Vascular is recalling 58 units of the Thunder Extra Support Guidewire, including models THNDR190J, THNDR190S, THNDR300J, and THNDR300S. These steerable guide wires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature.
The recall was initiated due to a potential for the polytetrafluoroethylene (PTFE) coating to delaminate and detach from the guidewire. The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries.
The source text does not specify instructions for consumers or healthcare providers regarding the handling of these devices.
The recalled product
- Product
- THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may b
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Guidewire
- Hazard
- Affected units
- 58
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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