ConcertoTM NV-3-4-HELIX (UDI 00847536033511)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536033511), received between Jul 7, 2020 and Mar 13, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL WOULD NOT DETACH. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT¿S CONDITION BEING TREATED WAS UNKNOWN. THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WAS UNKNOWN. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895985 ↗
• MalfunctionApr 28, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE DOCTOR PUSHED THE COIL OUT OF THE MICROCATHETER INTO THE PATIENT'S VESSEL WITH A SALINE FLUSH, AND EVERYTHING ENDED UP FINE. IT WAS NOTED THAT THE COIL HAD EXPERIENCED RESISTANCE IN THE MIDDLE OF THE CATHETER. THERE WAS NO DAMAGE TO THE COIL OR CATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN ENDOLEAK. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A TERUMO PROGREAT 2.8 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240718 ↗
• MalfunctionApr 21, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL BROKE INSIDE THE SHEATH/MICROCATHETER. THE PATIENT WAS BEING TREATED FOR AN ENDOLEAK. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS REMOVED FROM THE PATIENT. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS FRICTION 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 PROCEDURE. CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14169033 ↗
• MalfunctionJul 26, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WOULD NOT DETACH. THE 3RD COIL WAS PLACED INTO THE ANEURYSM AND ADVANCED WITH NO ISSUES. IT WAS NOTED THAT MANUAL DETACHMENT WAS AT THE PROPER MARK BUT THE COIL WOULD NOT DETACH. A MANUAL DETACHMENT WAS ATTEMPTED VIA HYPOTUBE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SPLENIC ANEURYSM WITH A MAX DIAMETER OF 2.9 MM AND A NECK DIAMETER 2.2 MM. THE VESSEL TORTUOSITY WAS SEVERE WITH A NORMAL BLOOD FLOW. THE PATIENT SUFFERED FROM SULFA AND ADHESIVE ALLERGIES, CIRRHOSIS, GERD, ASTHMA AND HYPERTENSION. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ISSUES DURING THE PROCEDURE PRIOR TO THE NON-DETACHMENT. THERE WAS NO PUSHWIRE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12224828 ↗
• MalfunctionApr 9, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE HAD NOT BEEN ANY ISSUES PRIOR TO THE NON-DETACHMENT, AND THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640956 ↗
• InjuryNov 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE NO ADVERSE EVENTS TO REPORT. NO INFORMATION COULD BE PROVIDED REGARDING HOW THE PROCEDURE WAS COMPLETED AND WHERE THE COIL REMAINED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10887330 ↗
• MalfunctionJul 7, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THE CONCERTO COIL FAILED TO DETACH WITH THE INSTANT DETACHER AND VIA THE MANUAL DETACHMENT METHOD. THE COIL WAS REPLACED, AND THE PROCEDURE CONTINUED. IT IS UNKNOWN IF A SECOND INSTANT DETACHER WAS USED. THE NUMBER OF DETACHMENT ATTEMPTS WAS NOT REPORTED. NO PATIENT INJURY WAS REPORTED TO HAVE OCCURRED. THIS EVENT OCCURRED DURING A COIL EMBOLIZATION PROCEDURE. THE CUSTOMER WAS NOTIFIED TO RETURN THE DEVICE FOR ANALYSIS. IT IS UNKNOWN IF THE DEVICE WAS PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE ANCILLARY DEVICES WERE DISCARDED AT THE SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10243041 ↗

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