Avigo 103-0606-200Recalls & reported problems
Micro Therapeutics, Inc. · GUIDEWIRE 103-0606-200 V05 AVIGO MDR · Class 2
Data updated Oct 16, 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 00763000518905), received between May 9, 2025 and May 9, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2025Break; Material Separation; Break; Material Separation
MEDTRONIC RECEIVED A REPORT THAT AN AVIGO GUIDEWIRE WAS BROKEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF BASILAR ARTERY THROMBOSIS. IT WAS REPORTED THAT THE SHEATH WAS INSERTED FROM THE FEMORAL ARTERY. THE 8FGUIDING WAS INSERTED INTO THE TON-BRIDGE MEDICAL 6F115 I NTERMEDIATE CATHETER TO REACH THE BASILAR ARTERY. THE AVIGO GUIDEWIRE PASSED THROUGH THE THROMBUS AND CARRIED THE MICROCATHETER REBAR18 COAXIALLY THROUGH THE THROMBUS. WHEN THE AVIGO GUIDEWIRE WAS WITHDRAWN, THE DEVELOPING SEGMENT AT THE TIP WAS NOT WITHDRAWN. THE OPERATOR PUSHED FORWARD AND BACKWARD AND FOUND THAT IT WAS BROKEN. THEY THEN PUSHED THE TON-BRIDGE MEDICAL 6F115 INTERMEDIATE CATHETER TO THE DISTAL END TO COVER THE MICROCATHETER. USED AN INTRACARDIAC 2X15 BALLOON AND 15 PRESSURES TO INFLATE AND SQUEEZE THE RESIDUAL GUIDEWIRE IN THE INTERMEDIATE CATHETER, THEN WITHDREW IT, AND SUCCESSFULLY REMOVED THE INTERMEDIATE CATHETER GUIDEWIRE AND THE RESIDUAL MICROCATHETER OUT OF THE BODY. AFTER REMOVAL FROM THE BODY, THE BROKEN PART WAS ABOUT 10 CM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 21993013 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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