Medtronic Zinger Steerable Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling Zinger Steerable Guidewires because the PTFE coating may delaminate and detach from the device.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Medtronic Vascular is recalling specific models of Zinger Steerable Guidewires. The recall is due to a potential for the polytetrafluoroethylene (PTFE) coating to delaminate and detach from the guidewire. The affected models are LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, and LVZRXT180S.
These steerable guidewires are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature. They are not intended for use in the cerebral vasculature. The recall covers units distributed worldwide, including the United States and numerous international countries.
The source text does not specify the total number of units recalled, specific lot numbers, or dates of distribution. No illnesses or injuries are reported in the provided text. Healthcare providers and facilities should stop using the affected devices and contact Medtronic Vascular for instructions on return or replacement.
The recalled product
- Product
- ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S 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
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Cardiovascular
- Affected units
- 5
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
FDA (Devices) · 2021-06-23
- SevereMedtronic Guide Catheter Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- SevereMedtronic Guide Catheter Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- HighMedtronic 6F Launcher Guide Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- SevereMedtronic Guide Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-03-17
Same hazard · coating delamination
See all →- CriticalDistal access catheters recalled after coating material lifting inside the lumen
FDA (Devices) · 2025-11-05
- SevereCenterline Biomedical IOPS Guidewire 2 Coating Delamination Risk
FDA (Devices) · 2025-05-28
- HighMicroVention Traxcess 7 Mini Guidewire Recalled for Coating Delamination
FDA (Devices) · 2017-09-13
- CriticalFDA Recalls Pipeline Embolization Devices Due to Coating Delamination
FDA (Devices) · 2016-11-16
- SevereEv3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires
FDA (Devices) · 2016-11-16