ZINGER® MEDIUM LVZRMS180SRecalls & reported problems
Medtronic, Inc. · GDWR LVZRMS180S ZINGRMS CRM 5PK 180 S HY · Class 2
All models of ZINGER MEDIUM (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169452305), received between Jul 2, 2018 and Mar 4, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).
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 Problem1
- Material Fragmentation1
- Material Separation1
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2019Material Separation; Material Separation
IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT OF THE LEFT VENTRICULAR LEAD, THE GUIDEWIRE WAS DESTROYED AND IT COULD NOT BE PULLED OUT FROM THE LEAD. THE LEAD WAS NOT IMPLANTED. THE GUIDEWIRE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8387013 ↗MalfunctionJul 9, 2018Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AND PLACEMENT OF THE LEFT VENTRICULAR (LV) LEAD, THE GUIDEWIRE WAS STUCK IN THE LEAD. THE PHYSICIAN CHOSE TO REPLACE THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7671085 ↗MalfunctionJul 2, 2018Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING DELIVERY SYSTEM WITHDRAWAL, A PIECE OF THE GUIDEWIRE WAS LEFT BETWEEN THE RIGHT VENTRICLE AND THE SUPERIOR VENA CAVA (SVC). THE SEGMENT WAS REMOVED WITH A SNARE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7655392 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
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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