ConcertoTM NV-3-8-HELIX (UDI 00847536013391)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00847536013391), received between Jun 26, 2018 and Jan 20, 2021 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOCTOR DID NOT REMEMBER FEELING ANY RESISTANCE OF THE COIL COMING OUT OF THE INTRODUCER SHEATH.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11204479 ↗
• MalfunctionJun 23, 2020Separation Failure; Separation Failure

  IT WAS REPORTED THE COIL WAS BEING USED AS PER THE IFU, BUT THE COIL DID NOT DETACH WITHIN THE VESSEL. A NEW COIL WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY. IT WAS NOTED THAT THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10187048 ↗
• MalfunctionMay 26, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), CLARIFIED THE COIL WOULD NOT DETACH INSIDE THE VESSEL. MEDTRONIC PRODUCTS WERE THEN USED TO COMPLETE THE PROCEDURE WITH NO ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10089547 ↗
• MalfunctionJun 28, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DETACH FROM THE MICROCATHETER. HOWEVER, AFTER REPLACING THE COIL, THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE ANATOMY WAS NORMAL IN TORTUOSITY. 2 TO 3 ATTEMPTS WERE MADE WITH THE INSTANT DETACHER AND 2 TO 3 MANUAL DETACHMENTS WERE MADE. THERE WERE NO ISSUES PRIOR TO THIS EVENT. THERE WAS NO DAMAGE TO THE PUSHWIRE WHEN IT WAS REMOVED. THE DEVICES WERE PREPARED AND USED PER THE IFU. ANCILLARY DEVICES INCLUDE A N EXCELSIOR 1018 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745961 ↗
• MalfunctionJun 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF CONCERTO COIL THAT STUCK INSIDE THE CATHETER DURING DEPLOYMENT. THE PATIENT WAS UNDERGOING COILING OF A GI BLEED. THE PATIENT ANATOMY WAS NORMAL. IT WAS REPORTED THAT DURING PLACEMENT, HALF OF THE COIL WAS OUT OF THE MICROCATHETER INTO THE PATIENT AND THE OTHER HALF WAS STILL IN THE MICROCATHETER. THE COIL REPORTEDLY BECAME LOCKED AND COULD NOT BE ADVANCED. THE COIL WAS REMOVED FROM THE PATIENT. THE MICROCATHETER WAS FLUSHED. THE SAME COIL WAS ATTEMPTED TO BE USED BUT COULD NOT ENTER THE HUB. NO PATIENT INJURY WAS REPORTED. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE IMPLANT COIL WAS BROKE FROM THE PUSHWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672366 ↗
• MalfunctionMay 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF CONCERTO COIL PREMATURE DETACHMENT IN A CATHETER. THE COILS WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSH LINE USED AND WAS MAINTAINED DURING THE EMBOLIZATION PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED WHEN THE COILS WERE ADVANCED INTO THE CATHETER. THERE WAS NO ALLEGATION OF A PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8655854 ↗
• MalfunctionMay 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF CONCERTO COIL PREMATURE DETACHMENT IN A CATHETER. THE COILS WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSH LINE USED AND WAS MAINTAINED DURING THE EMBOLIZATION PROCEDURE. RESISTANCE WAS NOT ENCOUNTERED WHEN THE COILS WERE ADVANCED INTO THE CATHETER. THERE WAS NO ALLEGATION OF A PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8655813 ↗
• MalfunctionApr 3, 2019Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF CONCERTO COIL PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR RIGHT BRANCH OFF THE SUBCLAVIAN VEIN IN MID ARTERY FISTULA. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. THE DEVICE WAS PREPPED PER THE IFU AND NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL WAS DEPLOYED INTO MICRO CATHETER. IT BECAME STUCK AND COULDN'T BE PUSHED FORWARD INTO THE VESSEL. COIL WAS REMOVED BUT IN THE REMOVAL PROCESS IT BECAUSE STUCK IN THE MICROCATHETER AND WAS DEPLOYED. THE CATHETER WAS REMOVED WITH THE COIL INSIDE. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8480643 ↗
• MalfunctionMar 28, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THIS COIL DID NOT DETACH DURING THE PROCEDURE. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8462244 ↗
• MalfunctionMar 28, 2019Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF CONCERTO PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING COILING OF A GI BLEED. THE PATIENT ANATOMY WAS NORMAL (NOT TORTUOUS AND NOT A HIGH FLOW RATE.) THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS REPORTED THAT DURING THE PROCEDURE, COILS HAD BEEN PLACED IN THE PATIENT. A FINAL COIL (CONCERTO 3-8) WAS ATTEMPTED TO BE PLACED. THE COIL REPORTEDLY BECAME JAMMED IN THE MIDDLE SECTION OF THE CATHETER. THE WIRE WAS PUSHED, THEN BENT, AND THE COIL DETACHED INTO THE MICROCATHETER. EVERYTHING WAS PULLED FROM THE PATIENT. THE FINAL RUN SHOWED EMBOLIZATION AND THE PROCEDURE WAS ENDED. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461668 ↗
• InjuryMar 8, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE COIL WAS JAMMED IN MIDDLE THE MICROCATHETER AND THEN PREMATURELY DETACHED IN THE MICROCATHETER WAS IT WAS BEING PULLED OUT. THERE AS NO DAMAGE ON THE MICROCATHETER, BUT SOME DAMAGE ON THE COIL. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF A BLEED. THE PATIENT¿S VASCULATURE WAS MODERATE IN TORTUOSITY AND THE BLOOD FLOW WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405789 ↗
• MalfunctionMar 8, 2019Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THE COIL HAD DIFFICULTY ADVANCING THROUGH THE PROGREAT CATHETER WHICH CAUSED IT TO KINK AND THEN PREMATURELY DETACH. THE DETACHED IMPLANT COIL REMAINED IN THE CATHETER AND NOTHING WAS IN THE PATIENT. THE PUSHWIRE WAS BENT AND BROKEN BUT NOT ON PURPOSE. THE PUSHWIRE WILL NOT BE RETURNED AS IT WAS DISCARDED. THE COIL WAS NOT REPOSITION NOR WAS AN ATTEMPT TO DETACH MADE. THE PHYSICIAN DID ROTATE THE DELIVERY PUSHER. NO CONTINUOUS FLUSH WAS ADMINISTERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405469 ↗
• MalfunctionNov 16, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT OF AN UNRUPTURED ANEURYSM, THIS COIL WOULD NOT ABLE TO DETACH AT THE TARGET LOCATION. IT WAS REPORTED THAT WHILE FOLLOWING THE IFU MANUAL, THE PHYSICIAN HARDLY DETACHED THE COIL ON THE TARGET VESSEL. SO THE PHYSICIAN TOOK THE NEW CONCERTO COIL AND FINISHED THE CASE WELL WITHOUT ANY INJURIES. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE PATIENT¿S BLOOD FLOW WAS NORMAL. THE VESSEL WAS MODERATELY TORTUOUS. NO PATIENT INJURY WAS REPORTED. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8077948 ↗
• MalfunctionNov 14, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT OF CONCERT COIL NON-DETACHMENT. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED ANEURYSM. VESSEL TORTUOSITY WAS DESCRIBED AS MODERATE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS REPORTED THAT "WHILE FOLLOWING THE IFU, THE PHYSICIAN HARDLY DETACH THE COIL ON THE TARGET VESSEL (B/O RESISTANCE)". THE COIL WAS REPLACED WITH A NEW COIL TO CONTINUE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT. THERE ARE NO IMAGES AVAILABLE FOR REVIEW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8071080 ↗
• MalfunctionJun 26, 2018Failure to Advance

  THREE CONCERTO DETACHABLE COILS WOULD NOT ADVANCE IN THE MICROCATHETER. THEY ARE SUPPOSED TO ADVANCE SMOOTHLY AND DEPLOY. THE REASON THREE WERE OPENED WAS THE REQUEST OF THE PHYSICIANS WHO WERE TRYING TO EMBOLIZE. NOT SURE THE REASONING BUT NONE WERE SUCCESSFUL. THE THREE LOT NUMBERS INVOLVED ARE A551401, A225811, AND A593437.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7637446 ↗