MicroMewiTM 41064-01Recalls & reported problems
Micro Therapeutics, Inc. · INF CATH 41064-01 MICROMEWI V03 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536008038), received between Mar 15, 2019 and Apr 4, 2019 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Device Dislodged or Dislocated1
Patient problems
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2019Break; Break
MEDTRONIC RECEIVED A REPORT THAT THE NURSE WAS TAKING THE DRESSING OFF THE CATHETER AND IT BROKE INTO 2 PIECES. AT THIS POINT THROMBOLYSIS HAD BEEN COMPLETED AND THE CATHETER WAS REMOVED. THERE WERE NO CATHETER SEGMENTS OR FRAGMENTS STUCK ON THE GUIDEWIRE, AND ALL SEGMENTS WERE RETRIEVED. THERE WERE NO RELATED PATIENT SYMPTOMS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8485598 ↗InjuryMar 24, 2019Break; Break
MEDTRONIC RECEIVED A REPORT THAT MARKERS WERE "LEFT IN PATIENT." THERE IS REPORTEDLY NO FURTHER INFORMATION ABOUT THE CATHETER. THE PATIENT WAS UNDERGOING THROMBOLYSIS WHEN THE EVENT OCCURRED.
Patient problems: Foreign Body In Patient
MAUDE report 8446767 ↗MalfunctionMar 15, 2019Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
MEDTRONIC RECEIVED INFORMATION THAT MICRORMEWI GOT CAUGHT INSIDE OF CRAGG MCNAMARA AND TIP DISLODGED INSIDE OF THE CATHETER. IT WAS REPORTED THAT THE PHYSICIAN PUT THE MICROMEWI THROUGH A CRAGG MCNAMARA. THE STAFF WAS NOTIFIED THAT THIS USAGE IS OFF LABEL AND PROBABLY CONTRIBUTED TO THE MICROMEWI GETTING STUCK INSIDE. THE TARGET LOCATION WAS LEFT MIDDLE SUPERFICIAL FEMORAL ARTERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. INSTRUCTION FOR USE (IFU) WAS NOT FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8424918 ↗
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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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