ConcertoTM NV-2-8-HELIX (UDI 00847536033504)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00847536033504), received between May 26, 2020 and Oct 6, 2022 — classified as 2 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (21 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COILS EXPERIENCED RESISTANCE AND WERE STUCK IN THE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEAL HAD SENT THE WRONG COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15555715 ↗
• MalfunctionAug 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT A DIFFERENT CONCERTO COIL WAS USED IN THE PROCEDURE, AND THE CASE WENT WELL. THERE WAS NO ALLEGED PRODUCT ISSUES, AND THERE WAS NO PATIENT INVOLVED IN THE EVENT. THE DEVICE WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CONCERTO COIL DETACHED PREMATURELY SO IT WAS REMOVED AND DISCARDED. ANOTHER COIL WAS THEN USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15310717 ↗
• MalfunctionAug 10, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WOULD NOT DEPLOY. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201196 ↗
• MalfunctionJun 5, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599699 ↗
• 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 14548676 ↗
• 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 14548641 ↗
• MalfunctionMay 10, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL COULD NOT BE DETACHED. A SECOND INSTANT DETACHER WAS ATTEMPTED, AND NO MANUAL DETACHMENT ATTEMPTS WERE MADE. TWO OTHER CONCERTO COILS WERE STUCK IN A NON-MEDTRONIC CATHETER. 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 14347521 ↗
• MalfunctionApr 18, 2022Separation Failure; Separation Failure

  2022-APR-06 MEDWATCH (HCP): MEDTRONIC RECEIVED A REPORT THAT THE 3 COILS COULD NOT BE DEPLOYED. THE COILS WERE REMOVED WITH NO HARM TO THE PATIENT. NEW COILS WERE PLACED WITHOUT INCIDENT OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137388 ↗
• MalfunctionApr 4, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE DETACHED AFTER SEVERAL ATTEMPTS BY THE PHYSICIAN. THE COIL WAS REPLACED, AND 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 13996072 ↗
• MalfunctionApr 1, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO WAS NOT DETACHED. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. ANCILLARY DEVICES INCLUDE: TERUMO PROGREAT 2.4F MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13973414 ↗
• MalfunctionMar 31, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL DID NOT DETACH. THE DEVICES WERE PREPARED ACCORDING TO INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS BEING USED AS PER THE IFU BUT THE COIL DID NOT DETACH FROM ITS WIRE (BOTH MANUAL METHOD AND DETACHER WERE TRIED SEVERAL TIMES). A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13972045 ↗
• MalfunctionMar 28, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT FIVE CONCERTO COILS FAILED TO DETACH. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING TREATMENT FOR A GI BLEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13930383 ↗
• MalfunctionMar 28, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT FIVE CONCERTO COILS FAILED TO DETACH. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING TREATMENT FOR A GI BLEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13930371 ↗
• MalfunctionMar 28, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT FIVE CONCERTO COILS FAILED TO DETACH. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING TREATMENT FOR A GI BLEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13930341 ↗
• MalfunctionJan 18, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT 4 CONCERTO COILS HAD RESISTANCE, DEPLOYED BECAME STUCK IN THE CATHETER. IT WAS UNKNOWN IF THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE. THE COILS WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285156 ↗
• MalfunctionJan 18, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT 4 CONCERTO COILS HAD RESISTANCE, DEPLOYED BECAME STUCK IN THE CATHETER. IT WAS UNKNOWN IF THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE. THE COILS WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285100 ↗
• MalfunctionJan 18, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT 4 CONCERTO COILS HAD RESISTANCE, DEPLOYED BECAME STUCK IN THE CATHETER. IT WAS UNKNOWN IF THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE. THE COILS WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13285054 ↗
• MalfunctionJun 9, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971691 ↗
• MalfunctionJun 7, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COILS PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE RESISTANCE OCCURRED AT THE DISTAL END OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11949241 ↗
• 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 11939657 ↗
• MalfunctionMay 25, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DEPLOY AND WAS DEEMED FAULTY DURING THE PROCEDURE. NO FURTHER INFORMATION WAS REPORTED. REFER TO MANUFACTURER REPORT 2029214-2021-00612 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11878000 ↗
• MalfunctionMay 25, 2021Separation Failure; Unintended Movement; Separation Failure; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DEPLOY AND WAS DEEMED FAULTY DURING THE PROCEDURE. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11877960 ↗
• MalfunctionMay 4, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770293 ↗
• MalfunctionMay 3, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DEPLOY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761588 ↗
• MalfunctionApr 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE RENEGADE MICROCATHETER WAS DELIVERED TO THE TARGET LOCATION. THE CONCERTO COIL WAS THEN PREPARED AND LOADED INTO THE MICROCATHETER. AFTER A FEW ADVANCED OF THE DELIVERY WIRE, THE COIL SEEMED TO BE STUCK IN THE HUB OF THE MICROCATHETER. THE COIL WAS RECAPTURED INTO THE INTRODUCER SHEATH, AND BECAME STUCK IN THE HUB AGAIN WHEN TRYING TO DELIVER AGAIN. THE PHYSICIAN THEN TRIED TO PUSH THE COIL OUT OF THE INTRODUCER SHEATH, BUT THE COIL WOULD NOT ADVANCE. IT WAS ALSO REPORTED THAT THE COILS PUSHED OUT OF THE INTRODUCER SHEATHS SMOOTHLY. A NEW CONCERTO COIL WAS THEN PREPARED, BUT THE SAME ISSUES WERE ENCOUNTERED. THERE WAS NO DAMAGE TO THE CATHETER, AND THE DISTAL SEGMENT OF THE FIRST COIL PUSHWIRE WAS DAMAGED. THE PHYSICIAN PROCEEDED TO USE PUSHABLE COILS WITH NO PROBLEMS, AND THE PROCEDURE WAS COMPLETED. IT WAS INDICATED THAT ALL DEVICES WEREPREPARED 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 PORTAL VEIN VARICESE EMBOLIZATION. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ANCILLARY DEVICES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739684 ↗

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-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
• 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