ZINGER® MEDIUM ZNGRMS180SRecalls & reported problems
Medtronic, Inc. · GDWR ZNGRMS180S ZINGERMS 5PK 180 ST SIL · Class 2
All models of ZINGER MEDIUM (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169452633), received between May 23, 2019 and May 24, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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
- Material Deformation2
- Peeled/Delaminated2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2019Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
A ZINGER GUIDEWIRE WAS BEING USED TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS REPORTED TO BE MILDLY TORTUOUS, MODERATELY CALCIFIED AND EXHIBITING 75% STENOSIS. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE ANATOMY. NO DAMAGE WAS NOTED TO THE PACKAGING, NO ISSUES WERE NOTED TO THE DEVICE WHEN REMOVING FROM THE PACKAGING PER THE IFU. THE DEVICE WAS INSPECTED AND PREPPED PER THE IFU WITH NO ISSUES NOTED. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS NOT PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE APPEARED TO UNRAVEL OR BECOME STRETCHED UPON REMOVAL FROM THE PATIENT. THE WIRE APPEARED STRETCHED AND DID NOT RETAIN ITS SHAPE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8639675 ↗MalfunctionMay 23, 2019Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation
A ZINGER GUIDE WIRE WAS USED IN A PROCEDURE TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 70% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). NO ABNORMALITIES WERE REPORTED IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS 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 HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE APPEARED TO UNRAVEL OR BECOME STRETCHED UPON REMOVAL OF THE DEVICE FROM THE PATIENT. THE WIRE APPEARED STRETCHED AND DID NOT RETAIN ITS SHAPE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8636746 ↗
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- 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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