CONCERTO VERSA™ CV-18-65Recalls & reported problems
Micro Therapeutics, Inc. · Coil CV-18-65 Concerto Versa V02 · Class 2 · Implant
Data updated Oct 13, 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 00763000321864), received between Aug 25, 2021 and Aug 25, 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. How this data works · Data updated Oct 13, 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.
MalfunctionAug 25, 2021Separation Failure; Separation Failure
MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL DID NOT DETACH. THIS MALFUNCTION OCCURRED DURING A PHYSICIAN USABILITY STUDY WITH A SILICONE MODEL UNDER FLUOROSCOPY. PHYSICIAN DEPLOYED COIL INTO A SILICONE MODEL OF AN ANEURYSM, INTO WHICH A 16X65 VERSA HAD ALREADY BEEN DEPLOYED (THUS LEADING TO A DENSE COIL MASS). PER THE PROTOCOL OF THE USABILITY STUDY, THE MEDTRONIC TEAM ASKED THE PHYSICIAN TO MANUALLY DETACH THIS COIL. PHYSICIAN BROKE THE PUSHER AT THE EDGE OF THE BLACK HEAT SHRINK (HBI), AND THE COIL DID NOT DETACH (SHE PULLED BACK ON THE PUSHER AND THE COIL MOVED AND WITHDREW SEVERAL CENTIMETERS INTO THE CATHETER). THE TEAM ASKED HER TO PULL THE TWO PORTIONS OF THE PUSHER APART 1-2CENTIMETERS AND TRY AGAIN. SHE DID THIS, AND THE RELEASE WIRE BROKE; THE COIL WAS STILL ATTACHED TO THE PUSHER (SHE MOVED THE PUSHER AND THE COIL MOVED AS WELL). MEDTRONIC PERSONNEL ASKED HER TO BREAK THE PUSHER AGAIN 1 CM MORE DISTALLY (ON THE BLACK HEAT SHRINK) AND PULL THOSE PIECES APART. SHE DID, AND SHE ATTEMPTED TO RETRACT AGAIN; AGAIN, THE COIL WAS WITHDRAWN WITH THE PUSHER SEVERAL CENTIMETERS INTO THE CATHETER. SHE ADVANCED THE SYSTEM BACK INTO THE ANEURYSM, AND MEDTRONIC PERSONNEL ASKED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12366931 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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