ZINGER® SUPPORT ZNGRS180SRecalls & reported problems
Medtronic, Inc. · GDWR ZNGRS180S ZINGERS 5PK 180 ST SIL · Class 2
All models of ZINGER SUPPORT (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169452558), received between Nov 26, 2019 and Oct 6, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Detachment of Device or Device Component1
Patient problems
- Intimal Dissection2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CORE LAB NOTED A DISSECTION IN ONE OF THE BRANCHES OF THE RIGHT RENAL ARTERY DURING THE PROCEDURE (B)(6) 2019). THE PATIENT RECOVERED WITHOUT SEQUELAE. THE SITE ASSESSED THE EVENT AS DEFINITELY PROCEDURE RELATED AND POSSIBLY RELATED TO THE STUDY CATHETER. THE SPONSOR ASSESSED THE EVENT AS PROCEDURE RELATED AND POSSIBLY RELATED TO THE SPYRAL CATHETER.
Patient problems: Intimal Dissection
MAUDE report 9376280 ↗InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CORE LAB NOTED A DISSECTION IN ONE OF THE BRANCHES OF THE RIGHT RENAL ARTERY DURING THE PROCEDURE. THE PATIENT RECOVERED WITHOUT SEQUELAE. THE SITE ASSESSED THE EVENT AS DEFINITELY PROCEDURE RELATED AND POSSIBLY RELATED TO THE STUDY CATHETER. THE SPONSOR ASSESSED THE EVENT AS PROCEDURE RELATED AND POSSIBLY RELATED TO THE SPYRAL CATHETER.
Patient problems: Intimal Dissection
MAUDE report 9376212 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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