CONCERTO VERSA™ CV-9-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000321567), received between Mar 24, 2021 and Mar 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2021Separation Failure; Material Deformation; Separation Failure; Material Deformation

  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 11582628 ↗
• MalfunctionMar 24, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO VERSA PUSHER WIRE WAS STUCK IN THE INSTANT DETACHER AFTER DEPLOYMENT. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. PATIENT MEDICAL HISTORY INCLUDES ILIAC ARTERY ANEURYSM. ADDITIONAL INFORMATION RECEIVED REPORTED NO DAMAGE WAS OBSERVED TO THE COIL BY THE PHYSICIAN. THERE WAS SOME KINKING OF THE MICROCATHETER OBSERVED AND THE DEVICE WAS REPOSITIONED; IT WAS UNKNOWN IF THIS WAS A CONTRIBUTING FACTOR TO THE CONCERTO VERSA PUSHER WIRE BEING STUCK IN THE INSTANT DETACHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563520 ↗