Concerto Detachable Coil System NV-10-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00847536044999), received between Nov 17, 2022 and Sep 8, 2026 — classified as 2 deaths, 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (9 reports).

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 8, 2026Difficult or Delayed Positioning; Material Deformation; Unintended Movement; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677894 ↗
• MalfunctionMar 31, 2026Inadequacy of Device Shape and/or Size; Stretched; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED. ¿THE COIL DID NOT WIDEN¿ WAS CLARIFIED TO MEAN THAT ¿DROP¿ IS MORE APPROPRIATE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE REPORT THAT THE PUSHER REMAINED HANGING WAS CLARIFIED AS REFERRING TO PREMATURE COIL DETACHMENT. THE PUSHER WAS NOT STUCK IN THE INSTANT DETACHER. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. THERE WERE NO ATTEMPTS TO DETACH THE COIL USING THE INSTANT DETACHER BECAUSE THE COIL DETACHED PREMATURELY, AND NO ATTEMPTS WERE MADE USING THE MANUAL METHOD. NO ISSUES WERE ENCOUNTERED PRIOR, AND NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746928 ↗
• MalfunctionJan 21, 2026Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL "CUT OFF". NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. IT WAS UNKNOWN WHAT CONDITION WAS BEING TREATED OR WHAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136046 ↗
• MalfunctionDec 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL WAS STUCK IN THE PROTECTIVE SHEATH AND COULD NOT BE PUSHED OUT. IT WAS NOTED THAT THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL NEVER ENTERED THE PATIENT'S BODY, THEREFORE IT IS CONSIDERED THAT THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THERE WAS NO DAMAGE OBSERVED TO THE CONCERTO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772496 ↗
• MalfunctionSep 18, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN PULLING BACK, THE COIL DID NOT COMPLETELY DETACH FROM THE WIRE AND THE PHYSICIAN COULD NOT INSERT IT AGAIN AND REMOVE IT. BEFORE THAT, THE DOCTOR HAD ALREADY USED 3 CONCERTO COILS WITHOUT ANY PROBLEMS. THERE WAS NON-DETCHMENT. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS A MANUAL ATTEMPT TO DETACH VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088131 ↗
• MalfunctionJul 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL COULD NOT BE ADVANCED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS UNKNOWN WHETHER ANY PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22392747 ↗
• MalfunctionAug 14, 2024Separation Failure; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Separation Failure; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL COULD NOT BE RELEASED, WHEN TRYING TO REMOVE IT FROM THE CATHETER IT WAS NOT POSSIBLE SINCE IT WAS TRAPPED INSIDE THE CATHETER. IT WAS NOTED THAT EVERYTHING HAPPENED INSIDE THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982711 ↗
• MalfunctionJul 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE ADVANCED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS UNKNOWN IF ANY PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19841724 ↗
• MalfunctionJun 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS BEING USED AS PER THE IFU BUT THE COIL DID NOT PASS THROUGH THE MICROCATHETER THAT WAS USED IN THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE CATHETER WAS NOT A MEDTRONIC DEVICE. NO OTHER INFORMATION WAS KNOWN OR AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520190 ↗
• MalfunctionFeb 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DID NOT PASS THROUGH THE MICROCATHETER IN THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE CONCERTO COIL AND ANY ACCESSORY DEVICES WERE PREPPED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER USED WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18716864 ↗
• MalfunctionJan 9, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED ATTACHMENTS WAS ATTEMPTED MANUALLY. DETAILING WAS ATTEMPTED IN BOTH STAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479249 ↗
• MalfunctionOct 25, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL CAN'T DETACH. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18005062 ↗
• MalfunctionOct 24, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DID NOT DETACH. THE CONCERTO COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997237 ↗
• MalfunctionOct 24, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT CONDITIONS WERE NORMAL. THE PATIENT WAS BORN WITHOUT A LEFT SIDE SFA. THE PATIENT WAS HAVING EMBOLIZATION ISSUES AND NEEDED COILS. THE LEFT SIDE EXTERNAL ILIAC AND COMMON FEMORAL ARTERY WERE TREATED. THERE WERE NO ISSUES BESIDES THE COIL NOT DETACHING. THERE WAS NO DAMAGE TO THE PUSH WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994919 ↗
• DeathSep 29, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT UNDERWENT A GASTRIC VARICES PROCEDURE ON (B)(6) 2023. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2023 FOR TIPS PLACEMENT AND BEGAN EXPERIENCING SEVERE DECLINE IN HEALTH DUE TO COMPLICATIONS FROM SEPSIS AND GI BLEED ON (B)(6) 2023. THE PATIENT'S DATE OF DEATH WAS (B)(6) 2023. THE DECISION WAS MADE BY THE PATIENT'S SON TO MOVE TOWARD PALLIATION AS OPPOSED TO ICU ADMISSION. THE EVENT DATE WAS ASSESSED AS CLOSE TO THE PROCEDURE DATE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE PROCEDURE, NOT RELATED TO THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE CLARIFYING THIS EVENT RESULTED IN PROLONGED HOSPITALIZATION. THE EVENT HAD A FATAL OUTCOME. THE PATIENT BEGAN SUFFERING FROM SEPSIS IN THE CONTEXT OF GI BLEED ON (B)(6) 2023 WHILE ALREADY ADMITTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THE END DATE OF THE HOSPITALIZATION AND THE DATE OF THE FATAL OUTCOME WERE BOTH NOTED AS (B)(6) 2023, SO IT WOULD APPEAR THE SUBJECT WAS HOSPITALIZED AT THE TIME OF DEATH. THE FACILITY NAME AND LOCATION, AS WELL AS INFORMATION REGARDING AUTOPSY RECORDS ARE NOT COLLECTED IN THE ELECTRONIC CR

  Patient problems: Gastrointestinal Hemorrhage; Sepsis

  MAUDE report 17844498 ↗
• DeathSep 29, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT UNDERWENT A GASTRIC VARICES PROCEDURE ON (B)(6) 2023. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2023 FOR TIPS PLACEMENT AND BEGAN EXPERIENCING SEVERE DECLINE IN HEALTH DUE TO COMPLICATIONS FROM SEPSIS AND GI BLEED ON (B)(6) 2023. THE PATIENT'S DATE OF DEATH WAS (B)(6) 2023. THE DECISION WAS MADE BY THE PATIENT'S SON TO MOVE TOWARD PALLIATION AS OPPOSED TO ICU ADMISSION. THE EVENT DATE WAS ASSESSED AS CLOSE TO THE PROCEDURE DATE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE PROCEDURE, NOT RELATED TO THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE CLARIFYING THIS EVENT RESULTED IN PROLONGED HOSPITALIZATION. THE EVENT HAD A FATAL OUTCOME. THE PATIENT BEGAN SUFFERING FROM SEPSIS IN THE CONTEXT OF GI BLEED ON (B)(6) 2023 WHILE ALREADY ADMITTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THE END DATE OF THE HOSPITALIZATION AND THE DATE OF THE FATAL OUTCOME WERE BOTH NOTED AS (B)(6) 2023, SO IT WOULD APPEAR THE SUBJECT WAS HOSPITALIZED AT THE TIME OF DEATH. THE FACILITY NAME AND LOCATION, AS WELL AS INFORMATION REGARDING AUTOPSY RECORDS ARE NOT COLLECTED IN THE ELECTRONIC CR

  Patient problems: Gastrointestinal Hemorrhage; Sepsis

  MAUDE report 17844490 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD UNDERGONE A COIL EMBOLIZATION PROCEDURE TO TREAT GI BLEED IN WHICH 2 CONCERTO COILS WERE USED ON (B)(6) 2023. IT WAS REPORTED THAT THE COILS WERE SUCCESSFULLY DELIVERED AND DETACHED AS INTENDED FOR SUCCESSFUL TREATMENT OF THE TARGET VESSEL. THERE WERE NO REPORTED INTRA-OPERATIVE ISSUES.  ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH NOTED GI BLEED AND UNDERWENT AND ADDITIONAL PROCEDURE FOR GASTRIC VARICEAL GLUING. THE EVENT WAS RESOLVED AND THE PATIENT WAS DISCHARGED AGAIN ON (B)(6) 2023. THE SITE INVESTIGATION CONCLUDED THE EVENT WAS PROBABLY RELATED TO THE INDEX PROCEDURE BUT NOT RELATED TO THE CONCERTO COILS. THE MEDTRONIC STUDY SPONSOR ASSESSMENT CONCLUDED CONSERVATIVELY THAT THE EVENT WAS PROBABLY RELATED TO THE INDEX PROCEDURE AND POSSIBLE RELATED TO THE CONCERTO COILS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17238640 ↗
• MalfunctionNov 17, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS STUCK IN THE MICROCATHETER. THE DEVICE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS THE COIL WAS STUCK IN THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821175 ↗