CONCERTO VERSA™ CV-12-50 (UDI 00763000321680)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000321680), received between Aug 31, 2021 and Sep 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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.

• MalfunctionSep 1, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE AND PREMATURE DETACHMENT WITH A CONCERTO COIL IT WAS REPORTED THAT MALFUNCTION HAPPENED IN A SILICONE MODEL - NO PATIENT INVOLVED. PHYSICIAN DEPLOYED THIRD COIL INTO SILICONE ANEURYSM MODEL (TWO PREVIOUS COILS). PER PROTOCOL, PHYSICIAN WAS ASKED TO RETRIEVE COIL AND RE-DEPLOY IT AS IF THE COIL WERE THE WRONG SIZE. PHYSICIAN HAD BEGUN WITHDRAWING COIL BACK INTO CATHETER AND NOTED THAT THERE WAS SOME RESISTANCE DURING THE WITHDRAWAL. THERE WAS NO APPARENT REASON FOR RESISTANCE, SO PHYSICIAN CONTINUED WITHDRAWING, AND THE COIL PREMATURELY DETACHED. SUBSEQUENT COIL WAS DELIVERED THROUGH CATHETER WITH NO PROBLEMS OR RESISTANCE NOTED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE IFU. THERE WAS NO SURGICAL OR MEDICAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS FRICTION/DIFFICULTY DURING DELIVERY. THE COIL WAS REPOSITIONED IN THE PROCESS OF WITHDRAWING IT THE FIRST TIME. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE, AND A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. ANCILLARY DEVICES INCLUDE A 6F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406806 ↗
• MalfunctionAug 31, 2021Separation Failure; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Separation Failure; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO VERSA COIL THAT FAILED TO DETACH DURING A BENCHTOP TESTING USING A SILICONE MODEL. IT WAS REPORTED THE DEVICES WERE NOT PREPARED PER THE INSTRUCTIONS FOR USE (IFU); THERE WAS NO INSPECTION AND NO FLUSHING USED. THE PHYSICIAN DEPLOYED THE COIL PER THEIR TYPICAL PRACTICE. THE MANUFACTURER REPRESENTATIVE (REP) ASKED THE PHYSICIAN TO INSERT, FULLY WITHDRAW, AND THEN INSERT THIS COIL AGAINST. THE PHYSICIAN NOTED SOME FRICTION DESCRIBED AS THE COIL FELT "SCRATCHY" DURING INSERTION THROUGH THE WAVELOCK SHEATH. NO OTHER ISSUES WERE NOTED DURING DEPLOYMENT. HOWEVER, WHEN DETACHMENT WAS ATTEMPTED WITH THE INSTANT DETACHER (ID), THE COIL DID NOT DETACH AND COULD BE SEEN RETRACTING WITH THE PUSHER THROUGH THE CATHETER. THE COIL WAS REPOSITIONED IN THE ANEURYSM AND THE REP ATTEMPTED TO DETACH IT AGAINST WITH THE ID BUT THE COIL STILL DID NOT DETACH AND WAS PULLED BACK WITH THE DELIVERY SYSTEM DURING WITHDRAWAL. IT WAS NOTED THERE WAS NO ISSUE WITH THE INSTANT DETACHER. MANUAL DETACHMENT WAS THEN ATTEMPTED. THE PUSHER BROKE AT THE HBI AND THE PROXIMAL SECTION OF THE PUSHER WAS PULLED BACK A SUBSTANTIAL AMOUNT (MORE THAN 2CM) TO TRY TO RETRACT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393789 ↗