Medtronic Thunder Steerable Guidewire Recalled for Coating Delamination Risk
Medtronic Vascular is recalling 1,205 Thunder Steerable Guidewires because the PTFE coating may delaminate and detach from the device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (coating detachment) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Vascular is recalling 1,205 units of the Thunder Steerable Guidewire, model LVTNDR190S. The recall is due to a potential for the polytetrafluoroethylene (PTFE) coating to delaminate and detach from the guidewire.
These guide wires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature. The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries.
The source text does not specify instructions for consumers or healthcare providers regarding the immediate handling of these devices.
The recalled product
- Product
- THUNDER¿ Steerable Guidewire; Model: LVTNDR190S 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 be used to reach and cross a target le
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Guidewire
- Hazard
- Affected units
- 1,205
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 (1)
- G13A00116 G13A00936 GV260 GV846
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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