ConcertoTM NV-4-8-HELIX (UDI 00847536033535)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536033535), received between Oct 21, 2020 and Jul 27, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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.

• MalfunctionJul 27, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DID NOT DETACH. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118088 ↗
• MalfunctionApr 27, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL WOULD NOT DETACH. THE PATIENT WAS BEING TREATED FOR A GASTRO INTESTINAL BLEED. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  COIL WOULD NOT DETACH WHEN OUTSIDE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO DETACH WITH THE INSTANT DETACHER 2 TIMES. THEY DID NOT TRY ANOTHER INSTANT DETACHER OR ATTEMPT TO DETACH MANUALLY. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222242 ↗
• 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 12586467 ↗
• MalfunctionJul 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE END OF THE COIL WIRE WAS BENT. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS DAMAGE NOTICED UPON OPENING THE PACKAGE, AND PREPARATION WAS PERFORMED PRIOR TO THE DAMAGE BEING SEEN. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200645 ↗
• MalfunctionMay 27, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ISSUE DURING THE PROCEDURE PRIOR TO NON-DETACHMENT. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898213 ↗
• MalfunctionMay 4, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THE FOLLOWING WERE ALL UNKNOWN: HOW MANY DETACHMENT ATTEMPTS WERE MADE VIA INSTANT DETACHER, THE NUMBER OF DETACHMENT ATTEMPTS VIA MANUAL METHOD, LOT NUMBER OF INSTANT DETACHER, IF THERE ANY ISSUES PRIOR TO NON-DETACHMENT, AND IF THERE WAS ANY DAMAGE OBSERVED TO THE DEVICE AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769584 ↗
• MalfunctionOct 21, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN ATTEMPTED TO DEPLOY THE CONCERTO COIL TWICE WITH THE INSTANT DETACHER AS WELL AS MANUALLY, BUT THE COIL WOULD NOT DETACH. THE COIL WAS RETRIEVED SAFELY FROM THE PATIENT AND REPLACED WITH ANOTHER PRODUCT OF THE SAME SIZE TO COMPLETE THE PROCEDURE. IT WAS NOTED A SECOND INSTANT DETACHER WAS NOT USED, AND THERE WAS NO ISSUE WITH THE FIRST INSTANT DETACHER. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF MESENTERIC ARTERY EMBOLIZATION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL.

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

  MAUDE report 10709394 ↗

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