MirageTM 103-0608 (UDI 00847536004788)Recalls & reported problems
Micro Therapeutics, Inc. · 103-0608 MIRAGE · Class 2
Data updated Oct 18, 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 00847536004788), received between Mar 30, 2017 and Mar 30, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Delamination” (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 18, 2026.
Most reported problems
Device problems
- Delamination2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2017Delamination; Delamination
MEDTRONIC RECEIVED REPORT THAT DURING TESTING/ PREPARATION, THE GUIDEWIRE COATING WAS NOTED TO BE PEELING WHEN THE DEVICE WAS NAVIGATED THROUGH THE SHEATH. THIS DEVICE WAS NOT USED TO TREAT THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6448103 ↗MalfunctionMar 30, 2017Delamination; Delamination
MEDTRONIC RECEIVED REPORT THAT THE GUIDEWIRE COATING WAS PEELING WHEN THE DEVICE WAS NAVIGATED THROUGH THE SHEATH. THE EVENT OCCURRED INTRAOPERATIVE. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS NOT TREAT BUT MONITORED. THE PATIENT IS CURRENTLY ASYMPTOMATIC AND NO INJURY OCCURRED. THE ANATOMY WAS REPORTED TO HAVE BEEN TORTUOUS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6448101 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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