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.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire."
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…
- 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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