CONCERTO VERSA™ CV-4-15 (UDI 00763000321260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000321260), received between Mar 16, 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, 2021Difficult or Delayed Positioning; Detachment of Device or Device Component; Material Deformation; Difficult or Delayed Positioning; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE AND PREMATURE DETACHMENT WITH A CONCERTO COIL IT WAS REPORTED THAT THIS INCIDENT OCCURRED DURING A BENCHTOP STUDY IN A GLASS AND SILICONE MODEL WITH PHYSICIAN -NO PATIENT INVOLVEMENT. PHYSICIAN WAS DEPLOYING COIL INTO 4MM GLASS VESSEL MODEL AT THE END OF A TORTUOUS PARTIAL SPLENIC MODEL THROUGH 4F GLIDECATHETER. MODEL HAD APPROXIMATELY 300 ML/MIN FLOW OF BLOOD MIMICKING FLUID. PHYSICIAN WAS HAVING TROUBLE GETTING COIL TO ANCHOR IN THIS SITUATION SO BEGAN ROTATING THE CATHETER TO ATTEMPT TO TWIST COIL AND THEREBY GET IT TO "GRAB" THE VESSEL WALL. A KINK IN THE CATHETER WAS NOTED AT THE CELIAC TAKEOFF POINT FROM THE AORTA, POSSIBLY RELATED TO THE TWISTING. THE PHYSICIAN WAS MANIPULATING THE COIL AND NOTED THAT IT STOPPED RESPONDING (WITHDRAWING) WITH THE PUSHER AND SAID THAT IT HAD PREMATURELY DETACHED. PREMATURE DETACHMENT/BREAK OCCURRED WITH COIL PARTIALLY OUT OF CATHETER AND PARTIALLY IN. PHYSICIAN WAS ABLE TO REMOVE THE CATHETER AND COIL TOGETHER. THE COIL WAS PARTIALLY INSIDE THE CATHETER AND PARTIALLY OUT; IT WAS PHOTOGRAPHED AT THE TIME AND THEN REMOVED FROM THE CATHETER BY MEDTRONIC PERSONNEL AT THE SCENE FOR SAFE SHIPPING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406696 ↗
• MalfunctionMar 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU), WITH THE EXCEPTION OF USING A CONTINUOUS FLUSH. THE PATIENT WAS BEING TREATED FOR A 3.5 MM GDA (GASTRODUODENAL ARTERY) WITH NORMAL VESSEL TORTUOSITY. THE REMAINDER OF THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494818 ↗