ZINGER® MEDIUM ZNGRMS180HJRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169452664), received between Jan 8, 2019 and Feb 13, 2024 — classified as 2 injuries, 7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2024Entrapment of Device; Fracture; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Entrapment of Device; Fracture; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ATTAIN LEAD AND ONE ZINGER GUIDEWIRE DURING A PROCEDURE IN A NON-TORTUOUS, NON-CALCIFIED LESION. THE ZINGER GUIDEWIRE WAS INSPECTED, AND NO ISSUE WERE OBSERVED PRIOR OF USE. THE GUIDEWIRE WAS NOT PREPPED PER IFU. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE ZINGER AND LEAD WERE HEPARINIZED. IT WAS REPORTED THAT THE ZINGER GUIDEWIRE BROKE AND DE-SPIRALIZED DURING THE FINAL LEAD PLACEMENT IN AN ANTEROLATERAL VESSEL WITH NO TORTUOSITY. DURING THE EXTRACTION OF THE GUIDEWIRE, THE PROXIMAL PART OF GUIDEWIRE CAME OUT WHILE THE DISTAL END WAS STILL VISIBLE IN FLUOROSCOPY. IT WAS DECIDED TO REMOVE THE LEAD TO BETTER UNDERSTAND WHAT HAPPENED. THE LUMEN OF THE VESSEL WAS OBSTRUCTED; THEREFORE, A NEW LEAD AND A NEW GUIDEWIRE WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18695168 ↗
• MalfunctionFeb 8, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE LEFT VENTRICULAR (LV) LEAD AND ONE ZINGER GUIDEWIRE. IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT OF THE LEFT VENTRICULAR (LV) LEAD, THE ZINGER GUIDEWIRE BROKE INTO TWO INSIDE THE LUMEN OF THE LEAD. THERE WAS NO DAMAGE NOTED TO THE GUIDEWIRE PACKAGING. THERE WERE NO ISSUES REMOVING THE GUIDEWIRE FROM THE PACKAGING. THE ZINGER GUIDEWIRE WAS INSPECTED WITH ISSUES NOTED. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE J-SHAPE OF THE GUIDEWIRE OBSTRUCTED THE LUMEN OF THE LEAD AND THERE WAS NO OTHER WAY TO PROCEED. THE LEAD AND GUIDEWIRE WERE REMOVE AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668476 ↗
• 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 17237518 ↗
• MalfunctionMar 16, 2023Flaked; Material Deformation; Flaked; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE ONE ZINGER GUIDEWIRE AND ONE MEDTRONIC LEFT VENTRICULAR (LV) LEAD IN THE CORONARY SINUS DURING THE IMPLANT PROCEDURE. THE GUIDEWIRE WAS INSPECTED WITH NO ISSUES NOTED. THE GUIDEWIRE WAS PREPPED PER INSTRUCTIONS FOR USE (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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED PLACEMENT DIFFICULTY. THE GUIDEWIRE WAS NOTED TO BE DAMAGED AFTER REMOVAL FROM THE PATIENT. IT WAS DETAILED THAT THE GUIDEWIRE WAS UN-SHEATHED WHEN PULLED OUT FROM THE LEAD. THE LEAD WAS REMOVED AND A DIFFERENT LEAD WAS PUT IN ITS PLACE. IT WAS SUBSEQUENTLY REPORTED THAT THE HYDROPHILIC COATING CAME OFF THE GUI DEWIRE WHEN THE DEVICE WAS INSIDE THE PATIENT. THE GUIDEWIRE BECAME ENTRAPPED WITH THE LEAD. THERE WAS SO MUCH RESISTANCE THAT IT WAS NOT POSSIBLE TO WITHDRAW THE GUIDEWIRE FROM THE LEAD. NO EXCESSIVE FORCE WAS USED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY. NO PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551242 ↗
• MalfunctionDec 8, 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. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. 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. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STRETCHED COILS WERE NOTICED DURING REMOVAL. AFTER PLACING THE LEFT VENTRICULAR LEAD, THE GUIDEWIRE WAS ATTEMPTED TO BE REMOVED. IT WAS NOTICED THAT THE X-RAY MARKER TIP WAS PULLED APART. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939648 ↗
• MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE ZINGER GUIDEWIRE TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THEGUIDEWIRE DETACHED AT THE TIP. IT WAS OBSERVED THAT THE LEFT SIDE OF THE HEART HAD AN OBSTRUCTION SO ACCESS THROUGH THE RIGHT SIDE OF THE HEART WAS CARRIED OUT THROUGH THE CORONARY SINUS. TWO LEADS WERE IMPLANTED, ONE IN THE RIGHT VENTRICULAR AND ONE IN THE LEFT VENTRICULAR. UPON COMPLETION THE ZINGER GUIDEWIRE WAS REMOVED WITHOUT RESISTANCE, HOWEVER IT BROKE AT THE TIP OF THE DEVICE. IT WAS NOTED THAT PART OF THE WIRE REMAINS IN THE PATIENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15578526 ↗
• MalfunctionJul 8, 2022Material Deformation; Material Deformation

  ONE ATTAIN LEAD AND ONE ZINGER GUIDE WIRE WERE ATTEMPTED TO BE USED. THERE WAS NO DAMAGE NOTED TO THE ZINGER PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. IT WAS REPORTED THAT DURING A CRTP IMPLANT THE ZINGER GOT STUCK INSIDE THE LEAD. THE LEAD WAS REMOVED WITH THE GUIDE STILL STUCK AND CONTINUED THE PROCEDURE WITH A NEW LEAD AND GUIDE WIRE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14953358 ↗
• MalfunctionDec 20, 2021Difficult to Remove; Difficult to Remove

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A LEAD AND A ZINGER GUIDEWIRE TO TREAT A NON CALCIFIED, NON TORTUOUS LESION IN THE CORONARY SINUS. THE DEVICE WAS NOT INSPECTED. THE DEVICE WAS NOT PREPPED. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT ONCE THE PHYSICIAN HAD CHANNELED THE TARGET VESSEL AND HAD SCREWED THE STABILITY, AN ATTEMPT WAS MADE TO REMOVE THE WIRE. OTHER DEVICES WERE IN USE WITH THE WIRE WHEN ISSUE OCCURRED. DESPITE VARIOUS MANEUVERS ATTEMPTED, IT WAS NOT POSSIBLE TO FREE THE CATHETER. A NEW CATHETER WAS INSERTED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043482 ↗
• InjuryJan 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  A ZINGER WIRE WAS INTENDED TO BE USED DURING A CRT IMPLANT PROCEDURE. NO DAMAGE NOTED TO PACKAGING. NO ISSUES REMOVING THE DEVICE FROM THE PACKAGING AS PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE GUIDE WIRE WAS FLUSHED BEFORE USE. 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 DURING INSERTION/DELIVERY. DURING A CRT IMPLANT, THE RIGHT ATRIAL LEAD AND THE RIGHT VENTRICLE LEAD WERE IN PLACE. THE ZINGER WAS ADVANCED IN ORDER TO PLACE THE LEFT VENTRICULAR LEAD. SINCE THE DESIRED POSITION WAS NOT REACHED, THE OPERATOR WANTED TO RETRACT THE LEAD BUT IT WAS NOT POSSIBLE. AN ATTEMPT WAS MADE TO ADVANCE THE LEAD OVER THE GUIDEWIRE IN ORDER TO TRY TO LOOSEN THE ZINGER, BUT IT WAS NOT POSSIBLE AS THE WIRE WAS STUCK IN THE ANTERIOR BRANCH. AS THE ZINGER WAS PULLED IN, THERE WAS A LOT OF RESISTANCE AND THE PATIENT DEVELOPED VENTRICULAR ARRHYTHMIA. THE ENTIRE ZINGER WIRE WAS LEFT IN THE PATIENT, AND THE PATIENT WAS SENT FOR SURGICAL EXTRACTION OF THE ZINGER IN ANOTHER HOSPITAL WITH THORACIC SURGERY BACKUP. THE REMOVAL ATTEMPT WAS UNSUCCESSFU

  Patient problems: Arrhythmia; Device Embedded In Tissue or Plaque

  MAUDE report 8226399 ↗