ZINGER SUPPORTRecalls & reported problems across all models

We found 6 models of ZINGER SUPPORT by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between May 11, 2017 and Oct 24, 2024 — classified as 6 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (18 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 SUPPORT problems

ZINGER SUPPORT models

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

• ZINGER® SUPPORT LVZRXT180J

  WIRE, GUIDE, CATHETER
  9 reports
• ZINGER® SUPPORT ZNGRS180HJ

  WIRE, GUIDE, CATHETER
  9 reports
• ZINGER® SUPPORT ZNGRS180HS

  WIRE, GUIDE, CATHETER
  7 reports
• ZINGER® SUPPORT ZNGRS180S

  WIRE, GUIDE, CATHETER
  3 reports
• ZINGER® SUPPORT LVZRXT180S

  WIRE, GUIDE, CATHETER
  2 reports
• ZINGER® SUPPORT ZNGRS180HJ

  Wire, guide, catheter
  2 reports

Recent ZINGER SUPPORT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO ZINGER GUIDEWIRES WITH A LEFT VENTRICULAR (LV) LEAD TO NAVIGATE THE CORONARY SINUS. IT WAS REPORTED THAT THE FIRST GUIDEWIRE SHREDDED DURING MANEUVERS OF THE DEVICE. THE ENTIRE GUIDEWIRE WAS SUCCESSFULLY REMOVED. THE SECOND GUIDEWIRE GOT STUCK IN THE LV LEAD AND BOTH PRODUCTS HAD TO BE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS PLACED AS THERE WAS NO CAPTURE IN THE LEFT VENTRICLE, THE LEAD WAS NOT USED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520566 ↗
• MalfunctionAug 19, 2024Entrapment of Device; Deformation Due to Compressive Stress; Material Deformation; Entrapment of Device; Deformation Due to Compressive Stress; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE LV LEAD AND ONE ZINGER GUIDEWIRE TO PLACE A LEAD IN A NON-CALCIFIED NARROW VEIN, WITH MODERATE TORTUOSITY IN THE CORONARY SINUS. THE ZINGER GUIDEWIRE WAS INSPECTED WITH NO ISSUES. THE ZINGER GUIDEWIRE WAS PREPPED PER IFU WITH NO ISSUES. 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 LEAD COULD NOT BE ADVANCED IN THE NARROW VEIN. AFTER MULTIPLE ATTEMPTS, THE DECISION WAS MADE TO ABORT AND SWITCH TO LEFT BUNDLE BRANCH AREA PACING (LBBAP). WHEN THE LEAD AND WIRE WERE REMOVED FROM THE PATIENT, THE WIRE HAD FRAYED/COME APART AND COULD NOT BE REMOVED FROM THE LEAD. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999970 ↗
• 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 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 ↗
• 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 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 ↗
• MalfunctionOct 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE TWO RDN016 SYMPLICITY SPYRAL CATHETERS AND ONE G3 GENERATOR DEVICE TO TREAT A NON-TORTUOUS ILIAC ARTERY, NON-TORTUOUS RENAL ARTERY AND NON-CALCIFIED LESION IN THE RIGHT RENAL ARTERY. THE CATHETERS AND GENERATOR WERE PREPPED PER IFU. THE GENERATOR PREVENTATIVE MAINTENANCE WAS PERFORMED PER SCHEDULE. IT WAS REPORTED THAT AN ERROR CODE OCCURRED DURING USE/TREATMENT AND A CONNECTION ISSUE WAS ENCOUNTERED. IT WAS DETAILED THAT DURING THE INITIAL CONNECTION OF THE FIRST CATHETER, THE GENERATOR DISPLAYED THE MESSAGE "MEDTRONIC CATHETER NOT RECOGNIZED. PLEASE UNPLUG AND FULLY RE-INSERT". MULTIPLE ATTEMPTS WERE MADE, INCLUDING RESTARTING THE GENERATOR, PUSHING THE CABLE OF THE CATHETER IN THE GENERATOR SOCKET AND MOVING THE NEEDLES OF THE CATHETER, HOWEVER, THE CATHETER WAS NOT RECOGNIZED. THE SECOND CATHETER WAS ATTEMPTED TO USE BUT THE SAME MESSAGE WAS DISPLAYED. THE NEEDLES INSIDE THE CABLE OF THE SECOND CATHETER WERE MOVED AND AFTER SEVERAL ATTEMPTS THE GENERATOR DISPLAYED A MESSAGE 'NEW PATIENT'. AFTER THE CATHETER WAS INSERTED TO THE PATIENT THE GENERATOR DISPLAYED THE SAME MESSAGE 'NEW PATIENT'. AN ATTEMPT WAS MADE TO INSERT THE NEW PATIENT, HOWEVER, THE ME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549379 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryOct 1, 2020Material Fragmentation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Fragmentation; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE BECAME STUCK IN THE LEFT VENTRICULAR (LV) LEAD AND BROKE OFF. THE GUIDEWIRE IS STILL IN THE CORONARY VEIN. AN EXTRACTION WAS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617221 ↗

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