ZINGER® MEDIUM LVZRMS180JRecalls & reported problems
Medtronic, Inc. · GDWR LVZRMS180J ZINGRMS CRM 5PK 180 J HY · Class 2
All models of ZINGER MEDIUM (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169452312), received between Aug 9, 2017 and Jul 22, 2020 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (4 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
- Activation, Positioning or Separation Problem4
- Material Integrity Problem3
- Mechanical Problem3
- Break2
- Material Fragmentation1
Patient problems
- No Known Impact Or Consequence To Patient9
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
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 ↗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 THE LEAD WAS ATTEMPTED TO BE WITHDRAWN BUT WAS UNABLE TO WITHDRAW THE LEAD WITHOUT DISLODGING THE LEAD.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 ↗MalfunctionMar 12, 2019Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT DURING IMPLANT, THE GUIDEWIRE BECAME STUCK INSIDE THE LEAD AND WAS UNABLE TO BE RETRACTED. THE PHYSICIAN REMOVED BOTH THE LEAD AND GUIDEWIRE AND IMPLANT WAS ATTEMPTED WITH A NEW LEAD AS WELL AS A NEW GUIDEWIRE. DURING IMPLANT OF THE REPLACEMENT LEAD, THE NEW GUIDEWIRE AGAIN BECAME STUCK IN THE LEAD, HOWEVER THE GUIDEWIRE WAS EVENTUALLY ABLE TO BE RETRACTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8412741 ↗MalfunctionDec 19, 2018Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER SEVERAL MANEUVERS TRYING TO PLACE THE LEFT VENTRICULAR (LV) LEAD IN THE TARGET CORONARY VEIN, THE GUIDEWIRE GOT STUCK INSIDE THE LEAD. THE LEAD AND GUIDEWIRE WERE REMOVED AND THE PHYSICIAN TRIED TO PULL THE GUIDEWIRE OUT UNTIL IT BROKE THE GUIDEWIRE INSIDE THE LEAD LUMEN. THE LV LEAD AND GUIDEWIRE WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8179374 ↗MalfunctionNov 7, 2018Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE UNRAVELED IN THE LEFT VENTRICULAR (LV) LEAD AFTER SUCCESSFUL PLACEMENT IN THE CORONARY SINUS LATERAL VEIN. IT WAS NOTED THAT AFTER REMOVAL OF THE LV LEAD, THE LEAD WOULD NO LONGER ACCEPT A STYLET OR ANOTHER WIRE. THE LEAD WAS NOT USED, AND ANOTHER 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 8047641 ↗MalfunctionNov 6, 2018Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE UNRAVELED WHEN BEING REMOVED FROM THE LEFT VENTRICULAR LEAD AFTER IT WAS PLACED INTO VEIN. THE PHYSICIAN CUT THE WIRE AT THE PROXIMAL END OF THE LEAD, REMOVED THE LEAD AND WAS ABLE TO EXTRACT THE REMAINING PORTION OF THE WIRE FROM INSIDE THE LEAD. THE LEAD WAS EVALUATED AND DETERMINED TO BE UNDAMAGED AND WAS RE-IMPLANTED USING A DIFFERENT GUIDEWIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8043166 ↗MalfunctionMay 1, 2018Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE UNRAVELED. THE PHYSICIAN STATED THERE WAS NEVER ANY STICKING OF THE GUIDEWIRE IN THE LEFT VENTRICULAR (LV) LEAD AND THE PHYSICIAN PULLED BACK THE GUIDEWIRE AND THE WIRE HAD FALLEN APART WITH MANY THIN WISPY LIKE PIECES EVERYWHERE. THE DISTAL PORTION OF THE WIRE WAS STILL EXTERNALIZED AT THE LEAD TIP AND CAME BACK WITH THE LEAD BOTH TIMES. THE LEAD AND THE GUIDEWIRE WERE 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 7476406 ↗MalfunctionAug 9, 2017Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHILE EXTRACTING THE GUIDEWIRE FROM THE LEFT VENTRICULAR (LV) LEAD, THE PHYSICIAN FELT ABNORMAL RESISTANCE, WHICH WAS NOT FELT DURING LEAD PLACEMENT OVER THE GUIDEWIRE. AFTER THE TOTAL RETRACTION OF THE GUIDEWIRE, IT WAS OBSERVED THE GUIDEWIRE WAS FRAYED AND DAMAGED AND WITH A "DIFFERENT ASPECT" WHEN COMPARED TO THE BEGINNING. THE GUIDEWIRE AND LV LEAD WERE REPLACED DUE TO THE PHYSICIAN'S CONCERN THAT THE LV LEAD MAY HAVE HAD PARTICLES IN THE LEAD LUMEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6782247 ↗MalfunctionAug 9, 2017Mechanical Problem; Activation, Positioning or Separation Problem; Mechanical Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE BECAME STUCK AND THEN SHREDDED WHILE IN THE LEFT VENTRICULAR (LV) LEAD. THE PHYSICIAN WAS ABLE TO PULL THE GUIDEWIRE OUT, HOWEVER, IT WAS FALLING APART. 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 6779491 ↗
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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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