ZINGER® MEDIUM ZNGRMS180HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169452657), received between Mar 9, 2018 and Feb 8, 2024 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionFeb 8, 2024Entrapment of Device; Material Deformation; Material Integrity Problem; Entrapment of Device; Material Deformation; Material Integrity Problem

  AN ATTEMPT WAS MADE TO USE TWO ZINGER GUIDEWIRES AND ONE LEFT VENTRICULAR (LV) LEAD. NO CALCIFICATION OR STENOSIS AND LITTLE TORTUOS ITY WAS NOTED. THE GUIDEWIRES WERE BEING USED FOR LEAD PLACEMENT USING THE OVER THE WIRE (OTW) TECHNIQUE. THE ZINGER DEVICES WERE INSPECTED BEFORE USE WITH NO ISSUES NOTED. THERE WERE NO DIFFICULTIES NOTED WHEN LOADING THE GUIDEWIRES. THE SOFT TIP OF THE GUIDEWIRES WERE SLIGHTLY CURVED TO PROBE THE VEIN. THE FIRST ZINGER GUIDEWIRE DID NOT PASS THROUGH THE CELL OF A STENT OR A TIGHT CALCIFIED LESION DURING DELIVERY. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE FIRST ZINGER DEVICE. IT WAS REPORTED THAT AFTER THE PLACEMENT AND FIXATION OF THE LV LEAD IT WAS NOT POSSIBLE TO REMOVE THE ZINGER GUIDEWIRE. THE LV LEAD WAS PLACED TO THE POSTEROLATERAL POSITION AND AFTER THE FIXATION OF THE LEAD THE ZINGER GUIDEWIRE COULD NOT BE REMOVED. THE LEAD WAS REMOVED WITH THE GUIDEWIRE AND THE GUIDEWIRE WAS STULL STUCK IN THE LEAD. A DIFFERENT LV LEAD WAS USED WITH ANOTHER ZINGER GUIDEWIRE. THIS ZINGER GUIDEWIRE HAD A HIGH RESISTANCE AFTER SOME EXPLORATORY MOVEMENTS, AND WAS REMOVED. A NON-MEDTRONIC GUIDEWIRE WAS USED INSTEAD AND THE REPLACEMENT LV LEAD WAS POSITIONED A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667852 ↗
• MalfunctionMar 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ZINGER GUIDEWIRE AND ONE ATTAIN PERFORMA LEAD TO TREAT A MILDLY TORTUOUS AND NON-CALCIFIED LESION IN THE CANNULATION OF LATERAL VEINS OF CORONARY SINUS. THE GUIDEWIRE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. THE WIRE TIP WAS NOT FORMED. THE LESION WAS NOT PREDILATED. THERE WERE NO DIFFICULTIES NOTED WHEN LOADING THE LEAD ONTO THE GUIDEWIRE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS EXPERIENCED DURING INSERTION AND ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE GUIDE WIRE WAS USED DURING LV LEAD PLACEMENT. THE WIRE WAS PLACED AT THE TARGET VEIN, LEAD FOLLOWED THE WIRE AND IMMEDIATELY IT WAS NOT POSSIBLE TO MOVE THE WIRE IN THE LEAD. IT OCCURRED AT THE BEGINNING OF PROCEDURE. IT WAS THE FIRST PLACEMENT AND THE FIRST USAGE. BOTH PRODUCTS WERE REMOVED AND DAMAGE OF THE WIRE WAS OBSERVED. IT WAS REPORTED THAT THE WIRE WAS KINKED WHEN THE WIRE WAS IN PATIENT. RESISTANCE WAS NOTED DURING REMOVAL OF THE DEVICE. IT WAS STATED THAT IT WAS IMPOSSIBLE TO REMOVE THE WIRE FROM THE LEAD. EXCESSIVE FORCE WAS NOT USED. THE GUIDEWIRE REMAINED IN THE LEAD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445711 ↗
• DeathMar 9, 2018Component or Accessory Incompatibility; Material Deformation; Component or Accessory Incompatibility; Material Deformation

  THE PHYSICIAN INTENDED TO USE A ZINGER GUIDE WIRE IN A PROCEDURE TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION IN THE PROXIMAL - MID RIGHT CORONARY ARTERY (RCA) WITH 80% PROXIMAL STENOSIS AND 99% MID STENOSIS. THE PATIENT HAD NO PREVIOUS ANTERIOR PCI. THE PATIENT HAD NO PREVIOUS STENTS, OR OTHER PRODUCTS IMPLANTED. THE PATIENT HAD A CRITICAL OBSTRUCTION IN THE RIGHT CORONARY VESSEL CAUSED BY ATHEROMA. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. 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 AND EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED THAT THERE WAS LOW SUPPORT, POOR STEERABILITY/POOR NAVIGABILITY DURING DELIVERY TO THE TARGET LESION AND DEFORMATION OF THE GUIDEWIRE. OTHER DEVICES WERE IN USE WITH THE WIRE WHEN THE ISSUE OCCURRED, A LA6JR40 LAUNCHER GUIDE CATHETER, A PYTON KIT AND A 6F INTRODUCER (061102A). THERE IS NO EVIDENCE ABOUT THE USE OF AN ANGIOPLASTIC BALLOON FO

  Patient problems: Death; Intimal Dissection; Thrombus

  MAUDE report 7328315 ↗