CONCERTO VERSA™ CV-10-40 (UDI 00763000321628)Recalls & reported problems
Micro Therapeutics, Inc. · Coil CV-10-40 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 00763000321628), received between Jul 28, 2021 and Jul 28, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Material Deformation1
- 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 28, 2021Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE/KINKING OCCURRED WHEN THE TIP OF THE DEVICE WAS IN THE CATHETER LUMEN AND PAST THE HUB. IT HAD NOT ADVANCED FAR ENOUGH AT THE TIME OF THE KINK TO REMOVE THE PROTECTIVE WAVELOCK SHEATH YET. THE PHYSICIAN DID NOT NOTE ANY UNUSUAL BEHAVIOR WILE INITIALLY LOADING THE DEVICE INTO THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12242919 ↗
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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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