ZINGER® LIGHT ZNGRLS180HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169452985), received between Aug 10, 2021 and Jan 2, 2024 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathJan 2, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A MEDTRONIC ZINGER GUIDEWIRE AND AN INTUITION GUIDEWIRE. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING. ONLY MEDTRONIC DEVICES WERE USED IN THE PROCEDURE. ONE OF THE GUIDEWIRES WAS DAMAGED. IT WAS REPORTED THAT THE DEVICE WAS DETACHED IN PIECES AND ONE OF THE PIECES WAS IN THE BODY OF THE PATIENT AND REMAINED IN THE PATIENT. THEY COULD NOT GET IT FROM THE VESSELS AND AS A RESULT THE PATIENT DIED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18423861 ↗
• MalfunctionFeb 22, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING THE PROCEDURE A ZINGER GUIDEWIRE WAS UNABLE TO MOVE AND BECAME STUCK INSIDE THE LEFT VENTRICULAR (LV) LEAD. THE LEAD AND GUIDEWIRE WERE REMOVED AND REPLACED. NO DAMAGE WAS NOTED TO THE PACKAGING OF THE ZINGER GUIDEWIRE AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE ZINGER GUIDEWIRE WAS NOT INSPECTED. THE ZINGER GUIDEWIRE WAS FLUSHED BEFORE USE, WITH NO ISSUES NOTED. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. NO DIFFICULTIES WERE NOTED WHEN LOADING THE GUIDEWIRE. THE ZINGER GUIDEWIRE WAS NOT USED SUCCESSFULLY WITH OTHER DEVICES PRIOR TO DIFFICULTIES OCCURRING AS THIS WAS THE FIRST TIME IT WAS ATTEMPTED TO BE USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576435 ↗
• MalfunctionAug 10, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ZINGER GUIDEWIRE TO TREAT A NON CALCIFIED, MODERATELY TORTUOUS LESION LOCATED IN THE PROXIMAL DIAGONAL ARTERY WITH 90% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. IT WAS REPORTED THAT DAMAGE WAS NOTED TO THE DEVICE AND THE DEVICE DETACHED IN THE PATIENT. COIL SEPARATION OCCURRED TO THE DISTAL EXTREME OF THE DEVICE. THE TIP OF THE DEVICE DETACHED DURING ADVANCEMENT OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING A SAME SIZED ZINGER GUIDEWIRE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299467 ↗