ZINGER® LIGHT ZNGRLS180HJ (UDI 00763000569716)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000569716), received between Mar 29, 2024 and Jun 4, 2025 — classified as 3 malfunctions.

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

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.

• MalfunctionJun 4, 2025Entrapment of Device; Detachment of Device or Device Component; Material Deformation; Entrapment of Device; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ATTAIN LEFT VENTRICULAR (LV) LEAD AND ONE ZINGER GUIDEWIRE RESISTANCE WAS ENCO UNTERED WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE. THE LESION BEING TREATED WAS MILDLY TORTUOUS LOCATED IN THE MID CORONARY SINUS (CS) LATERAL VESSEL. THE GUIDEWIRE HAD BEEN INSERTED INTO THE CATHETER AND HAD REACHED THE LATERAL BRANCH OF THE CS AS INTENDED. HOWEVER, RESISTANCE WAS FELT WHEN IT WAS ATTEMPTED TO WITHDRAW THE GUIDEWIRE FROM THE CATHETER AND THE GUIDEWIRE HAD BECOME FRAYED. THE GUIDEWIRE WAS REMOVED AND UPON REMOVAL WAS OBSERVED TO BE DAMAGED. THE GUIDEWIRE WAS NOT INSPECTED PRIOR TO USE AND WAS NOT PREPPED PER IFU. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22138845 ↗
• MalfunctionMay 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE ZINGER GUIDEWIRE DURING A CARDIAC RESYNCHRONIZATION THERAPY (CRT) IMPLANT PROCEDURE. THE DEVICE WAS I INSPECTED WITH NO ISSUES. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE DETACHED INSIDE THE PATIENT. DURING THE CRT IMPLANT, HAVING CANULATED THE CORONARY SINUS WITH A SHEATH AND WITH A SUB-SELECTOR INSIDE, THE ZINGER GUIDEWIRE WAS BEING MANIPULATED. IT WAS THEN NOTICED THAT THE TIP WAS NOT MOVING. IT WAS ATTEMPTED TO RETRY THE WHOLE GUIDEWIRE WHEN IT WAS NOTICED THAT THE GUIDEWIRE'S TIP WAS BROKEN AND TRAPPED INSIDE THE CORONARY SINUS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339413 ↗
• MalfunctionMar 29, 2024Entrapment of Device; Detachment of Device or Device Component; Material Deformation; Entrapment of Device; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ZINGER GUIDEWIRE AND ONE ATTAIN LEAD. THE ZINGER GUIDEWIRE WAS INSPECTED AND PREPPED WITH NO ISSUES. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE GUIDEWIRE WRAPPED AROUND THE END OF THE LEFT VENTRICULAR (LV) LEAD AND THE GUIDEWIRE UNRAVELED WHEN ATTEMPTS WERE MADE TO REMOVE THE WIRE FROM THE LEAD. IT WAS NOTED THAT THE LV LEAD WAS DAMAGED AFTER IT WAS REMOVED WITH THE GUIDEWIRE. THE LV LEAD AND GUIDEWIRE WERE REPLACED WITH NEW PRODUCTS. THE GUIDEWIRE WAS REPLACED WITH A NON-MEDTRONIC GUIDEWIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002994 ↗