Medtronic Zinger Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling Zinger Stainless Steel Workhorse Guidewires because the PTFE coating may delaminate and detach.
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 delamination) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic Vascular is recalling specific models of the Zinger Stainless Steel Workhorse Guidewire. The recall is due to a potential for the polytetrafluoroethylene (PTFE) coating to delaminate and detach from the guidewire.
The affected products are steerable guide wires used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature. The recall covers 1,239 units distributed worldwide, including the United States and numerous international countries.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or intervent
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 1,239
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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