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.
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 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
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