CONCERTO VERSA™ CV-20-65Recalls & reported problems
Micro Therapeutics, Inc. · Coil CV-20-65 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 00763000321925), received between Mar 30, 2021 and Mar 30, 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
- 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.
MalfunctionMar 30, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking
MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO VERSA COIL THAT HAD RESISTANCE DURING DELIVERY AND DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A PROCEDURE FOR HYPOGASTRIC INTERNAL ILIAC EMBOLIZATION PRIOR TO ENDOVASCULAR ANEURYSM REPAIR (EVAR). VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE DEVICES WERE NOT INSPECTED OR PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE SURGEON WAS VERY EXPERIENCED IN CONCERTO COILING PROCEDURES AND OPTED INSTEAD TO NOT INSPECT AND HYDRATE THE COILS FIRST AND NOT USE A CONTINUOUS FLUSH. INSTEAD, THE CATHETER WAS FLUSHED WITH A SYRINGE PRIOR TO THE VERSA COIL BEING INSERTED AND BETWEEN EACH COIL. THE FIRST COIL USED WAS A VERSA CV-20X65 LOT B156255. THE HYPO WAS ANEURYSMAL DISTALLY WITH ACUTE AND SUBACUTE THROMBUS. THE PHYSICIAN USED A NON-TAPERED 4 FR GLIDE CATHETER 100CM LENGTH. THE COIL WAS NOT HYDRATED OR INSPECTED PRIOR TO USE BUT WAS KEPT STRAIGHT DURING INSERTION EXCEPT FOR ONE LARGE LOOP. THE PHYSICIAN LOADED THE VERSA INTO THE CATHETER UNTIL APPROXIMATELY 9 INCHES REMAINED FROM THE END OF THE COIL TO THE HUB. AT THIS POINT THE PHYSICIAN WENT TO REMOVE THE VERSA INTRODUCER SHEATH AND WENT TO ADVANCE THE PUSHWIRE. THE PU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11592811 ↗
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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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