GuardWire® GEZ6200USRecalls & reported problems
Medtronic, Inc. · KIT GEZ6200US GUARD 6F EZA 3-6 RX · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10721902644167), received between May 24, 2017 and May 24, 2017 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE PHYSICIAN INTENDED TO USE A GUARDWIRE DEVICE IN A DISTAL SAPHENOUS VEIN GRAFT (SVG) WHICH EXHIBITED MODERATE TORTUOSITY, SEVERE CALCIFICATION AND 90% STENOSIS. THE GUARDWIRE WAS REMOVED FROM PACKAGING PER IFU. THE DEVICE WAS INSPECTED AND APPEARED INTACT. THE DEVICE WAS PREPPED PER IFU. RESISTANCE WAS ENCOUNTERED WHEN TRYING TO CROSS THE LESION, WHILE TORQUING THE BALLOON BROKE AND THEN DETACHED FROM THE WIRE WHEN ATTEMPTING TO REMOVE THE BALLOON THROUGH A 6FR SHEATH. IT WAS SUCCESSFULLY RETRIEVED UTILIZING A SNARE. THE BALLOON HAD NOT BEEN INFLATED. THE PHYSICIAN WAS TRYING TO ADVANCE WIRE THROUGH A CALCIFIED LESION. NO PATIENT INJURY REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6587480 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.