Concerto Detachable Coil System NV-2-8-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00847536044883), received between Mar 28, 2022 and Sep 28, 2026 — classified as 3 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (40 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 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918404 ↗
• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918257 ↗
• MalfunctionAug 26, 2026Separation Failure; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453963 ↗
• MalfunctionAug 26, 2026Separation Failure; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453916 ↗
• MalfunctionAug 18, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308652 ↗
• MalfunctionAug 13, 2026Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241085 ↗
• MalfunctionAug 7, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173484 ↗
• MalfunctionJul 13, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25802716 ↗
• MalfunctionJun 30, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT WAS BEING USED AS PER THE INSTRUCTIONS FOR USE (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 DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE RESISTANCE WERE IDENTIFIED. RESISTANCE WAS REPORTED AT THE CATHETER HUB. THE COIL EXITED THE INTRODUCER SHEATH SMOOTHLY. CONTINUOUS SALINE FLUSHING WAS ADMINISTERED AND MAINTAINED IN ACCORDANCE WITH THE IFU. NO KINK OR DAMAGE WAS OBSERVED ON THE COIL OR THE CATHETER AFTER REMOVAL. THE CATHETER MODEL AND LOT NUMBER WERE REQUESTED BUT REMAIN UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669511 ↗
• MalfunctionJun 25, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR ANEURYSM. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE CONCERTO COIL WAS DEPLOYED IN THE HUB OF THE MICROCATHETER. THE COIL BECAME STUCK AT THE PROXIMAL CATHETER HUB. IT IS UNKNOWN WHETHER THE COIL PUSHED SMOOTHLY FROM THE INTRODUCER SHEATH. NO CATHETER OR COIL DAMAGE WAS REPORTED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A PROGRET MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623504 ↗
• MalfunctionMay 13, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO HELIX SPRING (COIL) DID NOT EVOLVE IN THE MAESTRO 2.1 MICROCATHETER AND DETACHED INSIDE THE MICROCATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING HEPATIC EMBOLIZATION SURGERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. 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 25161447 ↗
• MalfunctionApr 3, 2026Product Quality Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CONCERTO COIL WAS FROM TRUNK STOCK. THE LAST CYCLE COUNT WAS A MONTH PRIOR AND CYCLE COUNTS ARE CONDUCTED MONTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783842 ↗
• MalfunctionJan 30, 2026Difficult or Delayed Positioning; Therapy Delivered to Incorrect Body Area; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WOULD NOT TRACK INTO THE MICROCATHETER. THERE WAS COIL JAM. THERE WAS DIFFICULT PLACEMENT. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. THERE WERE NO ADDITIONAL STEPS OR SURGICAL INTERVENTIONS REQUIRED TO REMOVE OR SECURE THE COIL. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE VESSEL WAS NOT DAMAGED. THE TIP OF THE CATHETER WAS NOT UNDER STRESS. THE TIP OF THE CATHETER DID NOT MOVE DURING DEPLOYMENT. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE ANEURYSM DID NOT RUPTURE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT WERE REPORTED. ANCILLARY DEVICES INCLUDE A TERUMO PROGRESS 2.4 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222553 ↗
• MalfunctionJan 30, 2026Difficult or Delayed Positioning; Therapy Delivered to Incorrect Body Area; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE EVENT IS UNKNOWN AND THAT THE COIL WOULD NOT TRAVEL THROUGH THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR A SMALL VESSEL GASTROINTESTINAL (GI) BLEED. THE PATIENTS VESSEL TORTUOSITY WAS NORMAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR INJURY IN ASSOCIATION WITH THIS EVENT. THE PROCEDURE WAS COMPLETED USING DIFFERENT MEDTRONIC COILS. THE QUANTITY WAS CONFIRMED AS TWO DEFECTED CONCERTO COILS UNDER THE SAME LOT NUMBER THAT WOULD NOT TRAVEL THROUGH THE MICROCATHETER. THERE WAS CATHETER RESISTANCE IN THE MIDDLE OF THE DEVICE. THE COIL DID COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS CATHETER FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE COIL OR CATHETER AFTER REMOVAL. THE INFORMATION WAS NOT CONFIRMED/PROVIDED BY THE PHYSICIAN IT WAS DONE THROUGH THE LEAD TECHNICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222480 ↗
• MalfunctionJan 23, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL DID NOT DEPLOY. THE PRODUCT WAS REPLACED WITH A NON-MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24166914 ↗
• MalfunctionJan 23, 2026Separation Failure

  THE PRODUCT WAS REPLACED WITH A NON-MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24165164 ↗
• MalfunctionJan 22, 2026Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO HELIX COIL WAS DETACHED BEFORE USE. 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 24145672 ↗
• MalfunctionJan 15, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COILS WERE STUCK IN THE CATHETER AND ENCOUNTERED RESISTANCE IN THE SHEATH. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PRODUCTS BECAME STUCK INSIDE THE CATHETER AND THE COILS DID NOT ADVANCE. THEY WERE REPLACED WITH NEW ONES, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL REPORTEDLY BECAME LODGED INSIDE THE CATHETER AND WAS REMOVED WITH DIFFICULTY. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE CATHETER WAS NOT A MEDTRONIC DEVICE. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COILS WERE PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082688 ↗
• MalfunctionDec 4, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. A CONTINUOUS SALINE FLUSH WAS ADMINIS TERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716788 ↗
• MalfunctionNov 21, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED WITH A DIFFERENT COIL WITH UNKNOWN MAKE AND MODEL. THE CAUSE OF THE NON-DEPLOYMENT WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT, THE COIL WAS STUCK IN THE CATHETER (USED A HEADWAY 17 MICROCATHETER) AND UNABLE TO DEPLOY/EXIT CATHETER. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619558 ↗
• MalfunctionNov 10, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED. VESSEL TORTUOSITY WAS NORMAL. THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED. THE CATHETER USED WAS NOT A MEDTRONIC PRODUCT. UPON CLARIFICATION, THE CUSTOMER INDICATED THAT THE EVENT SHOULD BE DESCRIBED AS COIL STRETCHING RATHER THAN PREMATURE DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509835 ↗
• MalfunctionOct 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT A CONCERTO COIL WOULD NOT ADVANCE IN THE MICROCATHETER. IT WAS NOTED THAT THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THERE WERE NO ABNORMALITIES REPORTED RELATED TO THE PATIENT'S ANATOMY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286326 ↗
• MalfunctionOct 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT A CONCERTO COIL WOULD NOT ADVANCE IN THE MICROCATHETER. IT WAS NOTED THAT THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THERE WERE NO ABNORMALITIES REPORTED RELATED TO THE PATIENT'S ANATOMY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285412 ↗
• MalfunctionSep 18, 2025Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT IT WAS INITIALLY REPORTED THAT THE CONCERTO COIL COULD NOT BE RELEASED; HOWEVER IT WAS CLARIFIED THAT THIS WAS INCORRECT AND THE COIL WAS NEVER INSERTED INTO A MICROCATHETER, NOR WAS THERE ANY ATTEMPT TO DEPLOY IT. RATHER, UPON OPENING THE PACKAGING, IT WAS DISCOVERED THAT THE PUSHWIRE WAS BENT AT THE END, AND THEREFORE THE COIL WAS IMMEDIATELY DISCARDED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO PREPARATION WAS PERFORMED, AS THE KINK WAS ALREADY IDENTIFIED DURING UNPACKING. THE PROCEDURE WAS COMPLETED USING ADDITIONAL CONCERT COILS. THE CAUSE OF THE PUSHWIRE BENT COULD NOT BE DETERMINED. THERE WERE NO SIGNS OF TAMPERING WITH THE PACKAGING. THE PROXIMAL END WAS SECURED WITH THE BLACK CLIP. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23092611 ↗
• MalfunctionSep 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED REPORT THAT A CONCERTO COIL MALFUNCTIONED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052888 ↗

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