X-pedionTM 203-0602-200Recalls & reported problems
Micro Therapeutics, Inc. · 203-0602-200 XPEDION14 GUIDEWIRE 200CM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536006362), received between Jan 24, 2019 and Jan 24, 2019 — classified as 1 malfunction.
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
- No Apparent Adverse Event1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2019No Apparent Adverse Event; No Apparent Adverse Event
MEDTRONIC RECEIVED REPORT THAT WHEN THE X-PEDION GUIDEWIRE WAS INTRODUCED INTO WATER, THE WATER TURNED A GREENISH COLOR. IT WAS NOTED THERE WAS NO SOLUTIONS IN THE WATER, AND NO OTHER DEVICES WERE PLACED IN THE WATER PRIOR TO SUBMERGING THE X-PEDION GUIDEWIRE. ANOTHER MICROGUIDE WAS USED TO TREAT THE PATIENT. NO PATIENT INJURY OCCURRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8274252 ↗
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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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