Concerto Detachable Coil System NV-9-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536044982), received between Sep 29, 2023 and Aug 13, 2026 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 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.

• MalfunctionAug 13, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241950 ↗
• MalfunctionJul 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO WOULDN'T DEPLOY INTO THE SHEATH. ANOTHER COIL WAS OPENED AND USED. NO ADDITIONAL INFORMATION WAS KNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696257 ↗
• MalfunctionApr 3, 2024Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE DETACHED BY THE ID-1. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER TWO TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THE DOCTOR MENTIONED THE DELIVERY PUSHER IS STUCK IN THE DETACHER AND COULD BE DETACHED BY THE INSTANT DETACHER.  IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031559 ↗
• DeathSep 29, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT UNDERWENT A GASTRIC VARICES PROCEDURE ON (B)(6) 2023. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2023 FOR TIPS PLACEMENT AND BEGAN EXPERIENCING SEVERE DECLINE IN HEALTH DUE TO COMPLICATIONS FROM SEPSIS AND GI BLEED ON (B)(6) 2023. THE PATIENT'S DATE OF DEATH WAS (B)(6) 2023. THE DECISION WAS MADE BY THE PATIENT'S SON TO MOVE TOWARD PALLIATION AS OPPOSED TO ICU ADMISSION. THE EVENT DATE WAS ASSESSED AS CLOSE TO THE PROCEDURE DATE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE PROCEDURE, NOT RELATED TO THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE CLARIFYING THIS EVENT RESULTED IN PROLONGED HOSPITALIZATION. THE EVENT HAD A FATAL OUTCOME. THE PATIENT BEGAN SUFFERING FROM SEPSIS IN THE CONTEXT OF GI BLEED ON (B)(6) 2023 WHILE ALREADY ADMITTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THE END DATE OF THE HOSPITALIZATION AND THE DATE OF THE FATAL OUTCOME WERE BOTH NOTED AS (B)(6) 2023, SO IT WOULD APPEAR THE SUBJECT WAS HOSPITALIZED AT THE TIME OF DEATH. THE FACILITY NAME AND LOCATION, AS WELL AS INFORMATION REGARDING AUTOPSY RECORDS ARE NOT COLLECTED IN THE ELECTRONIC CR

  Patient problems: Gastrointestinal Hemorrhage; Sepsis

  MAUDE report 17844476 ↗