ZINGER® SUPPORT ZNGRS180HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169452572), received between May 11, 2017 and Mar 15, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 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 A PROCEDURE. IT WAS REPORTED THAT THE GUIDEWIRE BROKE/FRAYED IN THE LEAD AT THE BEGINNING OF THE MANIPULATION. THE GUIDEWIRE WAS STUCK IN THE LEAD. IT WAS DETAILED THAT THERE MAYBE A POSSIBILITY THAT A PIECE OF GUIDEWIRE MAY HAVE REMAINED IN THE CORONARY SINUS VEIN. NO FURTHER INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16544111 ↗
• MalfunctionFeb 2, 2023Detachment of Device or Device Component; Device Damaged by Another Device; Material Deformation; Detachment of Device or Device Component; Device Damaged by Another Device; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ZINGER GUIDEWIRE AND ONE ATTAIN LEAD FOR LEFT VENTRICULAR PACING LEAD PLACEMENT. THE GUIDEWIRE WAS NOT INSPECTED. THE GUIDEWIRE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE GUIDEWIRE WAS EXAMINED AND FLUSHED BEFORE USE WITH NO ISSUES NOTED. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. IT WAS DETAILED THAT A SUBCLAVIAN VEIN ACCESS APPROACH WAS USED AS IS COMMON IN CRT IMPLANTATION. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE GUIDEWIRE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE GUIDEWIRE WAS NOTED TO BE DAMAGED. THE ATTAIN LEAD WAS SUCCESSFULLY POSITIONED, HOWEVER, DAMAGE OF THE GUIDEWIRE WAS OBSERVED WHEN PULLING OUT OF THE PACING LEAD. THE DAMAGE NOTED TO THE GUIDEWIRE WAS DESCRIBED AS DISENTANGLEMENT AND COIL SEPARATION. THE GUIDEWIRE DID NOT BECOME ENTRAPPED IN THE LEAD. THE GUIDEWIRE WAS REMOVED FROM THE PACING LEAD WITHOUT PROBLEM. THERE WAS NO RESISTANCE NOTED DURING WITHDRAWAL OF THE DEVICE. THERE WAS NO COMPLAINT AGAINST THE LEAD. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16282188 ↗
• MalfunctionMay 31, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ZINGER GUIDEWIRE AND ONE ATTAIN LEAD TO TREAT THE DISTAL CORONARY SINUS. 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 PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. DURING THE ZINGER DEVICE REMOVAL FROM THE PATIENT, DAMAGE WAS NOTED. IT WAS REPORTED THAT THE ZINGER SUPPORT BROKE. THE ZINGER DEVICE REMAINED IN THE LEAD AND WAS REMOVED TOGETHER WITH THE LEAD. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545725 ↗
• InjuryFeb 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE ZINGER GUIDEWIRE TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION LOCATED IN THE MID SUPERIOR VENA CAVA (SVC). IT WAS STATED THAT THE WIRE WAS USED DURING AN IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE TIP WAS NOT FORMED BY THE PHYSICIAN. IT WAS REPORTED THAT DAMAGE TO THE DEVICE WAS NOTED AND THAT THE DISTAL END OF THE WIRE BROKE WHILE PULLING THE DEVICE OUT OF THE PATIENT. IT WAS STATED THAT UNDER FLUOROSCOPY THE BROKEN END OF THE WIRE WAS FOUND AND WAS EXTRACTED USING A LASSO. IT WAS ALSO STATED THAT THE WIRE KINKED IN THE PATIENT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11278733 ↗
• MalfunctionFeb 25, 2019Material Deformation; Material Deformation

  A ZINGER GUIDEWIRE WAS INTENDED TO BE USED DURING A PROCEDURE. THE DEVICE WAS PLACED IN THE CORONARY SINUS (CS). NO DAMAGE NOTED TO PACKAGING. NO ISSUES REMOVING THE DEVICE FROM THE PACKAGING AS PER IFU. DEVICE WAS INSPECTED AND PREPPED AS PER IFU. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT DAMAGE WAS NOTED TO THE DEVICE AFTER REMOVAL FROM THE PATIENT. RESISTANCE WAS EXPERIENCED DURING REMOVAL. THE WIRE HAD BEEN PLACED BESIDE THE 4798-88 CM ATTAIN STABILITY QUAD AND BOTH WERE IN A 6250VI-EH ATTAIN COMMAND. DURING REMOVAL OF THE WIRE, THE OUTER WRAPPING OF THE WIRE WAS DAMAGED. NO PART OF THE WIRE WAS LEFT IN THE PATIENT. IT IS INDICATED THAT THE PHYSICIAN PULLED THE WIRE FORCEFULLY AND THIS IS WHAT MAY HAVE DAMAGED THE DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8365919 ↗
• InjuryDec 14, 2017Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  THE PHYSICIAN USED A ZINGER GUIDEWIRE IN A MODERATELY TORTUOUS LESION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS NOT INSPECTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT IS REPORTED THAT THE GUIDEWIRE BECAME STUCK IN THE ELECTRODE OF ANOTHER DEVICE IN USE AT THE TIME AND AFTER REMOVAL FROM THE PATIENT IT WAS NOTED THAT A PORTION OF THE ZINGER DEVICE DETACHED IN VIVO AND REMAINS IN THE PATIENT. NO PATIENT INJURY IS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7117063 ↗
• InjuryMay 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TARGET LESION WAS IN THE RCA. NO DAMAGE WAS NOTED TO PACKAGING OF A ZINGER GUIDEWIRE. NO ISSUES WERE NOTED TO THE DEVICE WHEN REMOVING FROM THE PACKAGING. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. 3 NON-MEDTRONIC STENTS WERE IMPLANTED. THE PHYSICIAN PLACED THE WIRE AND DELIVERED THE 3 NON-MEDTRONIC STENTS. WHEN REMOVING THE WIRE THE ZINGER GOT CAUGHT ON MIDDLE STENT AND THE MIDDLE STENT BECAME DEFORMED. PATIENT STARTED HAVING SYMPTOMS AND WAS TAKEN TO SURGERY. IT IS REPORTED THAT THE ZINGER WIRE DETACHED IN THE PATIENT. VESSEL OCCLUSION OCCURRED DUE TO DEVICE COMPONENT. THERE WAS VESSEL DAMAGE/INJURY. THE DETACHED PORTION WAS TRAPPED IN THE PATIENT. THE PHYSICIAN DOES NOT BELIEVE THE EVENT WAS DUE TO THE WIRE. THE PHYSICIAN THINKS IT WAS USER ERROR, THAT PERHAPS THE WIRE WAS PLACED TOO DEEP. IT IS REPORTED THAT THE PATIENT IS OK.

  Patient problems: Device Embedded In Tissue or Plaque; Occlusion; Patient Problem/Medical Problem; ST Segment Elevation; Thrombus; Vascular Dissection

  MAUDE report 6559550 ↗