ConcertoTM NV-7-30-HELIX (UDI 00847536013643)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536013643), received between Dec 19, 2018 and Apr 8, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL ENCOUNTERED DETACHMENT ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9941946 ↗
• MalfunctionAug 21, 2019Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  AS A RESULT OF THE ISSUE IT WAS REPLACED WITH ONE OF THE SAME SIZE. THE DISTAL PART OF THE COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER WHEN TRYING TO POSITION IN THE VESSEL. A CONTINUOUS FLUSH WAS USED, THE DEVICES WERE PREPARED PER THE IFU. IT WAS CONFIRMED THAT THE PATIENT'S VESSEL ANATOMY WAS MODERATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8917792 ↗
• MalfunctionMay 28, 2019Activation Problem; Activation Problem

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL DID NOT FORM A LOOP, WHEN IT WAS DEPLOYED. THE COIL APPEARED STRAIGHT AND ONLY MOVED FORWARD. THE COIL WAS RETRIEVED AND REDEPLOYED SEVERAL TIMES BUT STILL FAILED TO FORM A LOOP. THE COIL WAS REMOVED AND DISCARDED. A NEW COIL WAS SELECTED AND USED TO TREAT THE PATIENT. THE MAX DIAMETER WAS 2CM AND THE NECK WAS 6MM. NO PATIENT INJURY OCCURRED. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE SPLENIC ARTERY. THE PATIENT¿S VASCULATURE WAS MINIMAL IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL. THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION AND THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE VESSEL WAS NOT DAMAGED AND THE CATHETER WAS NOT UNDER STRESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8647857 ↗
• MalfunctionDec 19, 2018Incomplete or Missing Packaging; Incomplete or Missing Packaging

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE BOX WAS OPENED, THE COIL WAS PRE-DEPLOYED IN THE PACKAGING WITHIN THE BOX. THE COIL WAS REPLACED WITH ANOTHER ONE OF THE SAME SIZE. THE PATIENT WAS UNDERGOING TREATMENT FOR A SPLENIC ARTERY EMBOLIZATION. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8179186 ↗