ZINGER® LIGHT ZNGRLS180HJ (UDI 00643169452992)Recalls & reported problems
Medtronic, Inc. · GDWR ZNGRLS180HJ ZINGERLS 5PK 180 J HY · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169452992), received between Sep 8, 2017 and Oct 9, 2023 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Operates Differently Than Expected3
- Detachment of Device or Device Component1
- Material Deformation1
Patient problems
- Aortic Dissection3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation
AN ATTEMPT WAS MADE TO USE ONE ZINGER GUIDEWIRE DURING AN UPGRADE TO CARDIAC RESYNCHRONIZATION THERAPY (CRT) PROCEDURE. THE UPGRADE WAS BEING DONE TO IMPLANT A MEDTRONIC ATTAIN LEAD IN THE MID LATERAL VASUS WHICH ORIGINATED FROM THE CORONARY SINUS IN ORDER TO OBTAIN A CRT. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. ACCESS WAS GAINED IN THE LEFT SUBCLAVIAN VEIN. IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE WAS DAMAGED WHEN ATTEMPTING TO REACH THE LESION. THE GUIDEWIRE WAS INSIDE THE ATTAIN LEAD. THERE WERE NO DIFFICULTIES LOADING THE DEVICE INTO THE LEAD, THE GUIDE WAS LOADED AND THEN BECAME DAMAGED. THE GUIDEWIRE TIP FRAYED. THE GUIDE HAD NOT BEEN USED WITH OTHER DEVICES PRIOR TO THE EVENT. THERE WAS RESISTANCE WHILE REMOVING THE GUIDEWIRE FROM THE LEAD. A REPLACEMENT NON-MDT GUIDEWIRE WAS USED WITH THE SAME LEAD TO COMPLETE THE PROCEDURE. THE LEAD WAS LATER SUCCESSFULLY IMPLANTED WITH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17894597 ↗InjurySep 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT IS REPORTED THAT THE WIRE IS HARD, BAD TORQUE, TENDS TO DISSECT THE ARTERY WITH EASE. PATIENT PRESENTED WITH AORTIC DISSECTION WHEN WIRE WAS USED.
Patient problems: Aortic Dissection
MAUDE report 6851100 ↗InjurySep 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT IS REPORTED THAT THE WIRE IS HARD, BAD TORQUE, TENDS TO DISSECT THE ARTERY WITH EASE. PATIENT PRESENTED WITH AORTIC DISSECTION WHEN WIRE WAS USED.
Patient problems: Aortic Dissection
MAUDE report 6851091 ↗InjurySep 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT IS REPORTED THAT THE WIRE IS HARD, BAD TORQUE, TENDS TO DISSECT THE ARTERY WITH EASE. PATIENT PRESENTED WITH AORTIC DISSECTION WHEN WIRE WAS USED. WIRE DISCARDED.
Patient problems: Aortic Dissection
MAUDE report 6851084 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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