ConcertoTM NV-2-6-HELIX (UDI 00847536033498)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00847536033498), received between Jul 14, 2020 and Sep 13, 2022 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COILS WOULD NOT DEPLOY WITH THE INSTANT DETACHER (ID). OTHER COILS DEPLOYED WITH THE SAME DETACHER. THE CATHETER WAS NOT THE ISSUE. 2 ATTEMPTS WERE MADE WITH THE ID, THE PHYSICIAN DID NOT TRY ANOTHER ID AND DID NOT TRY A MANUAL ATTEMPT. THERE WERE NO ISSUES WITH THE ID.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A GI BLEED. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412140 ↗
• MalfunctionAug 17, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT PASS THROUGH THE MICROCATHETER. A REPLACEMENT COIL WAS USED TO COMPLETE THE PROCEDURE. 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 15245425 ↗
• MalfunctionJun 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT TWO CONCERTO COILS WERE STUCK IN THEIR SHEATHS DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14761341 ↗
• MalfunctionJun 17, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COILS WERE UNABLE TO DEPLOY. THERE WAS NOT SUCCESSFUL TREATMENT OF THE TARGETED VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14732445 ↗
• MalfunctionJun 1, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COILS WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH. THE RESISTANCE WAS AT THE DISTAL END OF THE CATHETER. THE CATHETER NOR THE COIL WERE DAMAGED. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE CONDITION BEING TREATED WAS A GI BLEED. THE PATIENT'S BLOOD FLOW WAS NORMAL AND THE VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566807 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A RIGHT COMMON FEMORAL PSEUDOANEURYSM FOLLOWING AN EMBOLIZATION PROCEDURE. SIX CONCERTO COILS HAD BEEN USED IN THE PROCEDURE. THE PATIENT WAS TREATED WITH CONCOMITANT MEDICATION AND PERCUTANEOUS INTERVENTION, AND THE EVENT RECOVERED/RESOLVED ON (B)(6) 2022. NO ADDITIONAL SURGICAL OR OPEN-REPAIR PROCEDURE WAS REQUIRED. ALL COILS HAD BEEN SUCCESSFULLY DELIVERED AND DETACHED WITH NO COMPACTION.

  Patient problems: Embolism/Embolus; Pseudoaneurysm; Thrombosis/Thrombus

  MAUDE report 14548724 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A RIGHT COMMON FEMORAL PSEUDOANEURYSM FOLLOWING AN EMBOLIZATION PROCEDURE. SIX CONCERTO COILS HAD BEEN USED IN THE PROCEDURE. THE PATIENT WAS TREATED WITH CONCOMITANT MEDICATION AND PERCUTANEOUS INTERVENTION, AND THE EVENT RECOVERED/RESOLVED ON (B)(6) 2022. NO ADDITIONAL SURGICAL OR OPEN-REPAIR PROCEDURE WAS REQUIRED. ALL COILS HAD BEEN SUCCESSFULLY DELIVERED AND DETACHED WITH NO COMPACTION.

  Patient problems: Embolism/Embolus; Pseudoaneurysm; Thrombosis/Thrombus

  MAUDE report 14548715 ↗
• MalfunctionFeb 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS STUCK IN THE CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF PERIPHERAL VASCULAR EMBOLIZATION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE COIL HAS BEEN EXPOSED A FEW TIMES OVER THE MICRO CATHETER TIP, SEEKING THE RIGHT POSITION/SHAPE. AFTER A FEW ATTEMPTS, IT LOOKED DETACHED WITHIN THE CATHETER AND EVEN THOUGH THE OPERATOR TRIED TO PUSH IT OUT, IT WAS STUCK IN THE CATHETER. IT HAS BEEN NECESSARY TO PULL BACK THE MICRO CATHETER WITH THE COIL STILL STUCK IN THE LUMEN. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. ANCILLARY DEVICES INCLUDE A RENEGADE STC-BSC MICROCATHETER. 2021-09-29 E1, E2 (REP): NO ADDITIONAL INFORMATION RECEIVED. 2021-NOV-02 E3 (REP): ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS NO DAMAGE OBSERVED. 2021-12-16 E4 (REP): NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13582314 ↗
• MalfunctionFeb 1, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE IT WAS NOTED THAT THE COIL WAS BENT IN THE MICROCATHETER AND DID NOT ADVANCE. THE PRODUCT WAS REPLACED WITH A MEDTRONIC PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419674 ↗
• MalfunctionJul 27, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO COIL NON-DETACHMENT NO ISSUES WERE ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233898 ↗
• MalfunctionJun 4, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE COIL WAS BEING USED AS PER THE IFU; HOWEVER, THE COIL DID NOT DETACH FROM ITS WIRE WITH EITHER THE INSTANT DETACHER OR MANUAL METHOD. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939929 ↗
• MalfunctionJun 4, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL DID NOT DETACH FROM ITS WIRE DURING THE PROCEDURE WHEN THE PHYSICIAN USED THE DETACHER WHILE THE COIL WAS WITHIN THE PATIENT BODY. THE COIL WAS REMOVED FROM THE PATIENT'S BODY AND WHEN THE PHYSICIAN TRIED TO DETACHED THE COIL OUTSIDE OF THE PATIENT'S BODY, IT DETACHED. THE COIL WAS DISCARDED ON THE SPOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939815 ↗
• MalfunctionMay 4, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THE COIL WAS BEING USED AS PER THE IFU, BUT IT COULD NOT BE DETACHED EITHER INSTANT DETACHER NOR MANUAL METHOD. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769784 ↗
• MalfunctionMar 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DISCONNECTED DURING ADVANCEMENT. THE PATIENT'S VESSEL CHARACTERISTICS AND NECESSITATION FOR TREATMENT WERE UNKNOWN, AND IT IS UNKNOWN IF THE DEVICES WERE PREPARED AS INDICATED PER THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575244 ↗
• MalfunctionFeb 10, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WOULD NOT RELEASE INTO THE VESSEL. THERE WERE 2-3 DETACHMENT ATTEMPTS MADE WITH THE INSTANT DETACHER, A SECOND INSTANT DETACHER WAS NOT USED, AND IT WAS UNKNOWN IF A MANUAL DETACHMENT ATTEMPT WAS MADE. IT WAS REPORTED THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE COIL WAS REMOVED FROM THE PATIENT, AND A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. 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 IN THE RIGHT HEPATIC. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A PROGREAT 2.4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307708 ↗
• MalfunctionDec 18, 2020Separation Failure; Separation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11038380 ↗
• MalfunctionSep 14, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE DEPLOYED. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, OR COMPLICATIONS. CLARIFICATION COULD NOT BE OBTAINED TO SPECIFY WHETHER NON-DETACHMENT OCCURRED, BUT ANALYSIS SUGGESTS NON-DETACHMENT OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10527738 ↗
• MalfunctionJul 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED A COMPETITOR'S COIL WAS USED TO COMPLETE THE PROCEDURE, AND A NON-MEDTRONIC CATHETER WAS USED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10273393 ↗

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