CONCERTO VERSA™ CV-6-20Recalls & reported problems
Micro Therapeutics, Inc. · Coil CV-6-20 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 00763000321352), received between Jul 16, 2021 and Jul 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
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.
MalfunctionJul 16, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT TWO VERSA COILS (CV-7-40, LOT #: B153515) AND A THIRD VERSA COIL (CV-8-40, LOT #: B153516) ADVANCED THROUGH THE MICROCATHETER AND DEPLOYED WITH NO ISSUES. THE MECHANICAL DETACHER WAS USED WITH NO SUCCESS, AND THE MANUAL DETACHMENT METHOD ALSO FAILED. EACH OF THE COILS WERE REMOVED SUCCESSFULLY. A CV-9-40 (LOT #: B153517) WAS DELIVERED AND DEPLOYED WITH NO ISSUES, BUT FAILED TO DETACH WITH THE INSTANT DETACHER AND MANUAL DETACHMENT METHODS. IT WAS NOTED THE WIRE BROKEN DURING THE MANUAL DETACHMENT WITH THIS COIL. A CV-5-30 (LOT #: B154329) WAS ADVANCED THROUGH THE MICROCATHETER AND DEPLOYED WITH NO ISSUES. IT WAS DETERMINED THE COIL WAS UNDERSIZED FOR WHAT WAS NEEDED AND REMOVED. WHEN USED LATER, THE COIL BECAME STUCK AT THE DISTAL END OF THE CATHETER AND DETACHED IN THE DISTAL TIP OF THE CATHETER. A CV-6-20 (LOT #: B154962) COIL WAS ADVANCED THROUGH THE MICROCATHETER AND DEPLOYED WITH NO ISSUES. IT WAS DETERMINED THE COIL WAS UNDERSIZED FOR WHAT WAS NEEDED AND REMOVED. WHEN USED LATER, THE COIL BECAME STUCK AT THE DISTAL END OF THE CATHETER. WHEN THE INSTANT DETACHER WAS USED WITH A COIL, THE PUSHWIRE WAS SEATED IN THE HUB OF THE INSTANT DETACHER. THE COIL WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12185849 ↗
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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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