ZINGER® SUPPORT LVZRXT180JRecalls & reported problems
Medtronic, Inc. · GDWR LVZRXT180J ZINGRXT CRM 5PK 180 J HY · Class 2
All models of ZINGER SUPPORT (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169452299), received between Aug 9, 2017 and Dec 26, 2019 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (3 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
Device problems
- Mechanical Problem3
- Activation, Positioning or Separation Problem2
- Material Fragmentation2
- Material Integrity Problem2
- Break1
- Detachment of Device or Device Component1
- Device Or Device Fragments Location Unknown1
Patient problems
- No Known Impact Or Consequence To Patient9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2019Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE PEELED OFF. THE GUIDEWIRE WAS REMOVED AND REPLACED WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9520526 ↗MalfunctionOct 17, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE GUIDEWIRE BROKE OFF WHILE IN THE LEAD. THE LEAD WAS IMPLANTED WITH A HALF INCH OF THE WIRE FRAGMENT HANGING OUT OF THE DISTAL END OF THE LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9205471 ↗MalfunctionMay 30, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING LEFT VENTRICULAR (LV) LEAD IMPLANT THE GUIDEWIRE GOT STUCK AFTER BEING PLACED AND MANEUVERED INSIDE THE LEAD, MAKING IT HARDLY REMOVABLE. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. THE GUIDEWIRE WAS RETURNED, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8656042 ↗MalfunctionMar 12, 2019Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE BECAME STUCK INSIDE THE LEAD. THE GUIDEWIRE AND LEAD WERE REMOVED AND A REPLACEMENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8413003 ↗MalfunctionMar 12, 2019Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING ATTEMPTED IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, A GUIDEWIRE BECAME STUCK AND WAS UNABLE TO PROGRESS FURTHER OR BE REMOVED FROM THE LEAD. THE LEAD WAS REMOVED AND A REPLACEMENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8412622 ↗MalfunctionMar 4, 2019Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING PLACEMENT OF THE LEFT VENTRICULAR (LV) LEAD, THE ZINGER WIRE BROKE OFF INSIDE THE LEAD BODY WHEN REMOVING THE WIRE. IT WAS NOTED THAT THE DISTAL END OF THE WIRE WAS IN THE LEAD AND COMING OUT OF THE END OF THE LEAD. THE LEAD AND WIRE WERE NOT USED 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 8386776 ↗MalfunctionAug 14, 2018Break; Break
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE BROKE. THE GUIDEWIRE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7781335 ↗MalfunctionMay 7, 2018Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN WAS MANIPULATING THE GUIDEWIRE IN LEFT VENTRICULE, IT WAS SUDDENLY DIVIDED INTO TWO BY THE DISTAL PART. THE PHYSICIAN DECIDED TO USE ANOTHER ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7491116 ↗MalfunctionAug 9, 2017Material Fragmentation; Mechanical Problem; Device Or Device Fragments Location Unknown; Material Fragmentation; Mechanical Problem; Device Or Device Fragments Location Unknown
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AFTER THE LEFT VENTRICULAR (LV) LEAD WAS PLACED IN THE VEIN, THE GUIDEWIRE WAS ATT EMPTED TO BE REMOVED, BUT IT WAS PEELED AND BROKE WITH A PART REMAINING INSIDE THE LEAD WITH THE DISTAL PORTION OF IT OUT AND INSIDE THE VEIN OF THE CORONARY SINUS. IT WAS ONLY POSSIBLE TO REMOVE ONE PORTION OF THE GUIDEWIRE AT FIRST, WHILE THE OTHER PORTION OF THE WIRE WAS STILL INSIDE THE LEAD IN THE VEIN. PULLING THE THREAD LEFT TO PEEL, THE PHYSICIAN MANAGED TO REMOVE ALL OF THE GUIDEWIRE WITHOUT FURTHER TROUBLE. IT WAS NOTED THAT THE GUIDEWIRE COATING WAS SEPARATED FROM THE WIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6782492 ↗
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- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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