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.
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 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…
- 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
Same manufacturer · Medtronic Vascular
See all →- SevereMedtronic Angiographic Guidewire Components Shipped Without Required Sterilization
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- SevereMedtronic Guide Catheter Recalled Due to Potential Sterility Compromise
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- SevereMedtronic Guide Catheter Recalled for Potential Sterility Compromise
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Same hazard · coating delamination
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FDA (Devices) · 2025-11-05
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- HighMicroVention Traxcess 7 Mini Guidewire Recalled for Coating Delamination
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- CriticalFDA Recalls Pipeline Embolization Devices Due to Coating Delamination
FDA (Devices) · 2016-11-16
- SevereEv3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires
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