ConcertoTM NV-4-10-HELIX (UDI 00847536033542)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536033542), received between Oct 29, 2020 and Jul 3, 2023 — classified as 2 deaths, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2023Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING DEPLOYMENT, THE CONCERTO COIL GOT DISLODGED BEFORE THE DETACHMENT FROM THE SYSTEM. IT WAS REPORTED COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE COIL REMAINED IN THE PATIENT. THE COIL WAS IMPLANTED IN THE INTENDED LOCATION. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS FRICTIONS OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A PROGREAT MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17247379 ↗
• MalfunctionOct 6, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL FAILED TO DETACH. SEVERAL DETACHMENT METHODS WERE ATTEMPTED, INCLUDING MANUAL DET ACHMENT. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15555644 ↗
• MalfunctionOct 13, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE LESION CHARACTERISTICS WERE RENTAL ARTERY PSEUDOANEURYSM - TWO SUBSEGMENTAL RENAL ARTERIES WERE COILED. THERE WAS MINIMAL VESSEL TORTUOSITY. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. IT WAS NOT KNOWN WHERE AND HOW THE FAILURE TOOK PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624639 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THERE WERE TWO CASES OF COILS THAT ACHIEVED HEMOSTASIS AND THE PATIENTS CAME BACK ABOUT A WEEK LATER WITH FLOW THROUGH THE COIL PACK. ADDITIONAL INFORMATION RECEIVED REPORTED 3 CONCERTO COILS WERE INVOLVED IN THE EVENT. THE INITIAL EMBOLIZATION PROCEDURE WAS COMPLETED WITH (B)(6) 2021; FLOW THROUGH THE COILS WAS OBSERVED AND THE PATIENT WAS SYMPTOMATIC. A SECOND EMBOLIZATION PROCEDURE OF THE SAME ARTERY WAS COMPLETED (B)(6) 2021. NO IMAGES WERE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12586496 ↗
• DeathSep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT WITH TWO HELIX CONCERTO COILS IMPLANTED (B)(6) 2021 DIED ON (B)(6) 2021. DETAILS AND CAUSE OF DEATH AND RELATIONSHIP TO THE COILS AND PROCEDURE WERE UNKNOWN AT TIME INITIAL INFORMATION WAS RECEIVED.

  Patient problems: Cardiac Arrest; Hematoma; Insufficient Information; Shock

  MAUDE report 12455203 ↗
• DeathSep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT WITH TWO HELIX CONCERTO COILS IMPLANTED (B)(6) 2021 DIED ON (B)(6) 2021. DETAILS AND CAUSE OF DEATH AND RELATIONSHIP TO THE COILS AND PROCEDURE WERE UNKNOWN AT TIME INITIAL INFORMATION WAS RECEIVED.

  Patient problems: Cardiac Arrest; Hematoma; Insufficient Information; Shock

  MAUDE report 12455061 ↗
• MalfunctionOct 30, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CONCERTO COIL HAD DETACHED WITHIN THE MICROCATHETER. NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE COIL WAS REMOVED FROM THE PATIENT. THE CATHETER MODEL INFORMATION WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10760218 ↗
• MalfunctionOct 29, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CONCERTO COIL HAD DETACHED WITHIN THE MICROCATHETER. NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE COIL WAS REMOVED FROM THE PATIENT. THE CATHETER MODEL INFORMATION WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10756290 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab