ZINGER® SUPPORT ZNGRS180HJ (UDI 00643169452589)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169452589), received between Jan 15, 2018 and Mar 28, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 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 DURING A PROCEDURE. THE ZINGER GUIDEWIRE WAS BEING USED TO SUPPORT LEAD PLACEMENT. IT WAS REPORTED THAT WHEN TRYING TO ADVANCE THE GUIDEWIRE INSIDE THE LEAD TO REACH THE TARGET POSITION IN THE VESSEL, THE GUIDEWIRE STRETCHED INSIDE THE LEAD BODY, AND BECAME DEFORMED AT THE DISTAL TIP. IT WAS NOT POSSIBLE TO PULL THE GUIDEWIRE BACK INSIDE THE LEAD, AND THE GUIDEWIRE CONTINUED TO STRETCH. THE GUIDEWIRE WAS ENTRAPPED IN THE LEAD, AND BOTH DEVICES HAD TO BE REMOVED TOGETHER. THE LEAD WAS NOT IMPLANTED, AND A NEW LEAD WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994761 ↗
• MalfunctionDec 4, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ON ZINGER CORONARY GUIDEWIRE DURING A PROCEDURE TO TREAT A MODERATELY TORTUOUS LESION IN THE DISTAL MEDIAL POSTERIOR VESSEL. THE DEVICE WAS INSPECTED WITH 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 GUIDE WAS BROKEN. THE GUIDEWIRE WAS IN USE WITH A 429888 LEAD WHEN ISSUE OCCURRED. WHEN WITHDRAWING THE GUIDEWIRE FROM THE LEAD IT WAS NOTICED THAT BY MOVING THE GUIDEWIRE BACK THE TIP REMAINED IN THE SAME POSITION. THE GUIDEWIRE HAD FRAYED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256084 ↗
• MalfunctionJun 30, 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 TWO ZINGER GUIDEWIRES AND ONE ATTAIN LEAD FOR LEFT VENTRICULAR (LV) PACING LEAD PLACEMENT IN THE ANTERO-LATERAL BRANCH OF CORONARY SINUS. THE DEVICES WERE INSPECTED WITH NO ISSUES BEING NOTED. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES NOTED. THE WIRE TIP ON BOTH DEVICES WERE NOT FORMED BY THE PHYSICIAN. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. IT WAS REPORTED THAT THERE WAS DAMAGED TO ZINGER GUIDEWIRES DURING REMOVAL FROM THE PATIENT. DURING LV LEAD POSITIONING, THE GUIDEWIRES HAD BEEN ADVANCED AND THEN PULLED BACK INSIDE THE LEAD. WHEN REMOVING THE GUIDEWIRES FROM THE LEAD, THE COILS OF THE GUIDEWIRES WERE NOTED TO BE STRETCHED. IT WAS ALSO DETAILED THAT OTHER DEVICES WERE IN USE WITH THE WIRES WHEN ISSUE OCCURRED. THE GUIDEWIRES WERE REPLACED WITH A NEW MEDTRONIC GUIDEWIRE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237519 ↗
• MalfunctionApr 26, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE ZINGER GUIDEWIRE IN A NON-TORTUOUS, NON-CALCIFIED LESION IN THE CORONARY SINUS VEIN. THE DEVICE WAS I NSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUE NOTED. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT DEVICE DETACHMENT IN VIVO OCCURRED AND RESISTANCE WAS EXPERIENCED DURING INSERTION. AFTER SUCCESSFUL CORONARY SINUS CANNULATION WITH THE ATTAIN COMMAND GUIDE CATHETER, THE ZINGER GUIDEWIRE WAS INTRODUCED THROUGH THE LEFT VENTRICLE (LV) LEAD WITH NO RESISTANCE OR COMPLICATIONS. HOWEVER, AFTER CANNULATING THE P OSTEROLATERAL VEIN AND ADVANCING THE LV LEAD OVER THE GUIDEWIRE, RESISTANCE WAS EXPERIENCED WHEN ATTEMPTING TO RETRACT THE LEAD. THE LEAD AND GUIDEWIRE DID NOT RETRACTED ENTIRELY AND PART OF THE GUIDEWIRE REMAINED IN THE PATIENT. IT WAS DETAILED THAT THE BROKEN GU IDEWIRE PORTION WAS ASPIRATED VIA THE GUIDE CATHETER. THE DETACHED PORTION WAS REMOVED FROM THE PATIENT. THE GUIDEWIRE AND LEAD WERE REPLACED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16813990 ↗
• MalfunctionMar 16, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ATTAIN PERFORMA LEAD AND ONE ZINGER GUIDEWIRE DURING AN IMPLANT PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE GUIDEWIRE PACKAGING. THERE WERE NO ISSUES NOTED TO THE GUIDEWIRE WHEN REMOVING FROM THE PACKAGING PER IFU. THE GUIDEWIRE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THERE WAS LEAD PLACEMENT DIFFICULTY. DURING IMPLANT THE GUIDEWIRE GOT STUCK IN THE LEAD. THE GUIDEWIRE DE-SPIRALIZED AND THE TIP BROKE OFF AT THE DISTAL END. IT WAS DETAILED THAT THE TIP FRAGMENT GOT STUCK IN A BRANCH OF THE CS (CORONARY SINUS). THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16560514 ↗
• MalfunctionMar 14, 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 IN A NON-TORTUOUS, NON-CALCIFIED LESION IN THE PROXIMAL INTERVENTRICULAR VEIN OF THE CORONARY SINUS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE WIRE TIP WAS 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. UPON ADVANCING THE GUIDEWIRE THROUGH THE LEFT VENTRICULAR (LV) LEAD IN THE TARGET VEIN, IT WAS REPORTED THAT THE GUIDEWIRE GOT STUCK IN THE LEAD. THE GUIDEWIRE COULD NOT BE PULLED FROM THE LEAD LUMEN SO BOTH THE LEAD AND THE GUIDEWIRE WERE REMOVED TOGETHER. THE GUIDEWIRE WAS THEN REMOVED FROM THE LEAD. IT WAS DETAILED THAT AFTER VISUAL INSPECTION THE GUIDEWIRE WAS COMPLETELY UNWRAPPED. THE GUIDEWIRE WAS REPLACED WITH A NEW GUIDEWIRE TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539123 ↗
• MalfunctionFeb 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE ZINGER GUIDE WIRE WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH HIGH % STENOSIS IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. 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. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING INSERTION OF THE DEVICE INTO THE HEMOSTATIC VALVE AND A PORTION OF THE DEVICE DETACHED INSIDE THE PATIENT WHILE TRYING TO ACCESS THE CORONARY SINUS. THE DETACHED PORTION WAS TRAPPED INSIDE THE PATIENT DISTALLY. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13522297 ↗
• MalfunctionAug 19, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ONE ZINGER GUIDE WIRE AND ONE ATTAIN LV LEAD WERE USED DURING A PROCEDURE TO TREAT A MILDLY TORTUOUS AND NON-CALCIFIED DISTAL CORONARY SINUS. THERE WAS NO PACKAGING NOTED TO THE PACKAGING OF THE ZINGER GUIDE WIRE, AND THE DEVICE WAS REMOVED FROM THE PACKAGING AS 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 WIRE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY OF THE GUIDE WIRE. THE WIRE WAS USED TO HELP POSITION THE LV LEAD. IT WAS REPORTED THAT ON REMOVAL THE WIRE BEGAN TO UNRAVEL AND THE DISTAL PORTION THAT WAS OUT OF THE TIP OF THE LEAD CAME LOOSE IN THE POSTEROLATERAL BRANCH OF THE CORONARY SINUS. NO ATTEMPT WAS MADE TO REMOVE THE DETACHED PORTION FROM THE PATIENT. THE DETACHED PORTION OF THE WIRE REMAINS IN THE POSTEROLATERAL BRANCH OF CORONARY SINUS. THE LV LEAD REMAINS IMPLANTED WITH NO PROBLEMS. THERE IS NO ALLEGED PRODUCT ISSUE AGAINST THE ATTAIN LEAD. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10424732 ↗
• MalfunctionJan 15, 2018Retraction Problem; Material Distortion; Retraction Problem; Material Distortion

  THE PHYSICIAN WAS USING A ZINGER WIRE WHEN PLACING A MEDTRONIC LV LEAD. THE LESION WAS NON-CALCIFIED AND NON-TORTUOUS, WITH NO STENOSIS. THE ZINGER WIRE WAS PREPPED PER IFU. NO RESISTANCE WAS NOTED WHEN WHEN ADVANCING THE WIRE IN THE VESSEL. NO RESISTANCE WAS NOTED WHEN LOADING THE WIRE THROUGH THE LEAD. NO FORCE WAS APPLIED TO THE WIRE DURING ADVANCEMENT. NO RESISTANCE WAS NOTED WHEN REMOVING THE WIRE FROM THE LEAD BUT THE WIRE CAME OUT STRETCHED LIKE A THREAD, AND THE RADIO-OPAQUE PART OF THE WIRE REMAINED IN THE LEAD. THE ENTIRE LEAD WAS TAKEN OUT. A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7189122 ↗