CONCERTO VERSA™ CV-3-15Recalls & reported problems
Micro Therapeutics, Inc. · Coil CV-3-15 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 00763000321208), received between Jun 29, 2021 and Jun 29, 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.
MalfunctionJun 29, 2021Separation Failure; Separation Failure
MEDTRONIC RECEIVED A REPORT THAT A PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A GI BLEED, AND ACCESS INTO THE CELIAC WAS OBTAINED WITH 5F C2 AND ANGLED GLIDE WIRE TO THE PROXIMAL GDA. THE FIRST OF THE 3X15 VERSA COILS WERE DEPLOYED THROUGH THE 5F ANGLED GLIDE. THE COIL TRACKED AND PACKED WELL ONCE FORMED. THE PHYSICIAN ATTEMPTED DEPLOYMENT WITH THE INSTANT DETACHMENT AND IT WAS UNSUCCESSFUL. THE MANUAL DETACHMENT WAS ATTEMPTED AND THE FILAMENT BROKE, TWO MORE ATTEMPTS WERE MADE MORE DISTAL, BUT THE FILAMENT BROKE AGAIN IN SHIRT SEGMENTS. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL, BUT THE ENTIRE SYSTEM JAMMED AND WOULD NOT MOVE IN OR OUT. A HEMOSTAT WAS USED ON THE PUSHWIRE TO ATTEMPT WITHDRAWAL WITHOUT SUCCESS. A PORTION OF THE COIL APPEARED TO HAVE STRETCHED BACK INTO THE CATHETER. THE SUPPORT SHEATH WAS ADVANCED INTO THE HEPATIC ARTERY TO MAINTAIN ACCESS, AND THE ENTIRE 5F CATHETER WAS REMOVED WITH THE COIL SUCCESSFULLY. A 4F ANGLED GLIDE CATHETER WAS THEN ADVANCED INTO THE GDA. A NEW 3X5 VERSA WAS DEPLOYED AND THE INSTANT DETACHER WAS ATTEMPTED THREE TIMES WITHOUT SUCCESS. THE MANUAL DETACHMENT WAS PERFORMED SUCCESSFULLY. A THIRD 3X5 VERSA WAS DEPLOYED, AND THE INSTANT D
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12088971 ↗
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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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