ZINGER MEDIUMRecalls & reported problems across all models

We found 5 models of ZINGER MEDIUM by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2017 and Feb 13, 2024 — classified as 1 death, 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ZINGER MEDIUM problems

ZINGER MEDIUM models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ZINGER® MEDIUM LVZRMS180J

  WIRE, GUIDE, CATHETER
  10 reports
• ZINGER® MEDIUM ZNGRMS180HJ

  WIRE, GUIDE, CATHETER
  9 reports
• ZINGER® MEDIUM LVZRMS180S

  WIRE, GUIDE, CATHETER
  3 reports
• ZINGER® MEDIUM ZNGRMS180HS

  WIRE, GUIDE, CATHETER
  1 death3 reports
• ZINGER® MEDIUM ZNGRMS180S

  WIRE, GUIDE, CATHETER
  2 reports

Recent ZINGER MEDIUM adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 22, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE GUIDEWIRE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10308985 ↗
• MalfunctionMay 24, 2019Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  A ZINGER GUIDEWIRE WAS BEING USED TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS REPORTED TO BE MILDLY TORTUOUS, MODERATELY CALCIFIED AND EXHIBITING 75% STENOSIS. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE ANATOMY. NO DAMAGE WAS NOTED TO THE PACKAGING, NO ISSUES WERE NOTED TO THE DEVICE WHEN REMOVING FROM THE PACKAGING PER THE IFU. THE DEVICE WAS INSPECTED AND PREPPED PER THE IFU WITH NO ISSUES NOTED. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS NOT PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE APPEARED TO UNRAVEL OR BECOME STRETCHED UPON REMOVAL FROM THE PATIENT. THE WIRE APPEARED STRETCHED AND DID NOT RETAIN ITS SHAPE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639675 ↗
• MalfunctionMay 23, 2019Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  A ZINGER GUIDE WIRE WAS USED IN A PROCEDURE TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 70% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). NO ABNORMALITIES WERE REPORTED IN RELATION TO THE ANATOMY. 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 AND PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS 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 HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE APPEARED TO UNRAVEL OR BECOME STRETCHED UPON REMOVAL OF THE DEVICE FROM THE PATIENT. THE WIRE APPEARED STRETCHED AND DID NOT RETAIN ITS SHAPE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636746 ↗
• MalfunctionMar 12, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, PLACEMENT DIFFICULTY WAS NOTED AND THE GUIDEWIRE WAS STUCK IN THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8413450 ↗
• MalfunctionMar 12, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE IMPLANTER INSERTED THE GUIDEWIRE INTO THE LEFT VENTRICULAR (LV) LEAD AND POSI TIONED THE LEAD. THE LEAD WAS ATTEMPTED TO BE WITHDRAWN BUT WAS UNABLE TO WITHDRAW THE LEAD WITHOUT DISLODGING THE LEAD. THE GUIDEWIRE WAS STUCK IN THE LEAD BODY AND FORCEFUL RETRACTION WAS NOT POSSIBLE. THE LV LEAD AND GUIDEWIRE WERE REMOVED AND REPLACED. NO PATI ENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8413354 ↗

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