CONCERTO VERSA™ CV-6-40Recalls & reported problems
Micro Therapeutics, Inc. · Coil CV-6-40 Concerto Versa V02 · Class 2 · Implant
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 00763000321383), received between Mar 26, 2021 and Mar 26, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (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.
Most reported problems
Device problems
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2021Separation Failure; Separation Failure
MEDTRONIC RECEIVED A REPORT THAT ONE COIL BECAME STUCK DURING DELIVERY, ONE COIL COULD NOT BE DETACHED, AND THREE COILS WERE DETACHED MANUALLY AFTER BEING UNABLE TO DETACH WITH THE INSTANT DETACHER. THE PATIENT WAS UNDERGOING TREATMENT FOR VARICES. THE PATIENT¿S BLOOD BLOW WAS HIGH, AND THE VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DELIVER THE FIRST COIL THROUGH BALLOON. THE VERSA 14X65 COIL DID NOT TRACK THROUGH THE BALLOON, AND THE PHYSICIAN RETRACTED THE COIL SUCCESSFULLY. IT WAS BELIEVED THAT THIS WAS DUE TO A SIZING ISSUE, AND THE BALLOON ID WAS LIKELY LARGER THAN 041. A NUMBER OF LEGACY CONCERTO COILS WERE THEN DELIVERED. AFTERWARDS, THE PHYSICIAN TRIED TO USE A VERSA COIL AGAIN WITH A 4F COBRA CATHETER. THE VERSA 6X40 COIL TRACKED WELL. THE PHYSICIAN DID NOT USE THE INSTANT DETACHER AND WENT STRAIGHT TO A MANUAL BREAK. THE WIRE BROKE AT THE HBI AND THE INTERNAL FILAMENT BROKE, BUT THE COIL DID NOT DETACH. THE PHYSICIAN TRIED BREAKING AT OTHER POINTS, BUT THE COIL STILL COULD NOT BE DETACHED. FIVE MANUAL DETACHMENT ATTEMPTS WERE MADE. THE COIL WAS WITHDRAWN SUCCESSFULLY. A VERSE 7X40 COIL TRACKED WELL AND DETACHED USING THE INSTANT DETACHE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11573335 ↗
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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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