ConcertoTM NV-2-8-HELIX (UDI 00847536013346)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00847536013346), received between Sep 27, 2017 and May 4, 2021 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (15 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• 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 11770165 ↗
• MalfunctionDec 22, 2020Separation Failure; Material Deformation; Separation Failure; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO THE COIL NON-DETACHMENT, THERE WERE NO ISSUES DURING THE PROCEDURE. AFTER THE COIL WAS REMOVED, IT WAS NOTED THAT THERE WAS KINK DAMAGE TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11060034 ↗
• 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 10187076 ↗
• MalfunctionJun 15, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PROCEDURE WAS COMPLETED WELL USING THE SAME PRODUCTS. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10155028 ↗
• MalfunctionMay 28, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THE COIL WOULD NOT DETACH IN THE VESSEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING MEDTRONIC PRODUCTS. OTHER DETAILED INFORMATION WAS UNKNOWN: VESSEL TORTUOSITY, THE NUMBER OF DETACHMENT ATTEMPTS, ANY DEVICE DAMAGE OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10096921 ↗
• MalfunctionMay 27, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE THE CONCERTO COIL DID NOT DETACH IN THE BLOOD VESSEL. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE PATIENT STATUS WAS NOTED TO BE ALIVE WITH INJURY AND IN STABLE CONDITION.

  Patient problems: Injury

  MAUDE report 10094708 ↗
• MalfunctionApr 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL THAT DETACHED PREMATURELY. IT WAS REPORTED THAT THE DEVICE WAS PREPARED AND TESTED PRIOR TO USE PER THE MANUFACTURER INSTRUCTIONS FOR USE. DURING THE PROCEDURE, THE DEVICE DETACHED PREMATURELY BY ITSELF. THE PHYSICIAN WAS ABLE TO REMOVE THE DEVICE FROM THE PATIENT'S VESSEL WITH A SNARE. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUE. THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9969815 ↗
• MalfunctionApr 8, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL ENCOUNTERED DETACHMENT ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9941927 ↗
• MalfunctionApr 8, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION: THE 3 CONCERTO COILS FAILURE TO DETACH. THERE WAS ONLY DIFFICULTY DETACHING THE COILS. AN INSTANT DETACHER (ID) WAS USED. THE MODEL AND LOT NUMBER OF THE ID IS UNKNOWN. THE NUMBER OF MANUAL ATTEMPTS IS UNKNOWN. THE MODEL AND LOT NUMBER OF THE CATHETER USED IS UNKNOWN. A CONTINUOUS FLUSH WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9941901 ↗
• MalfunctionDec 3, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL DID NOT PERFORMING AS INTENDED, AS THE COIL WAS UNABLE TO DETACHED. THE DEVICE WAS PREPARED AND USED PER THE INSTRUCTIONS (IFU). THE ANATOMY WAS SEVERE IN TORTUOSITY. THE TREATING LOCATION WAS THE PROSTATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9401472 ↗
• MalfunctionNov 22, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL FAILED TO DETACH. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). TWO DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER. A SECOND DETACHER AND MANUAL DETACHER WERE NOT USED. THE BLOOD FLOW AND THE VESSEL ANATOMY WERE BOTH NORMAL. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9364909 ↗
• MalfunctionSep 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PROCEDURE COULD NOT BE PERFORMED BECAUSE THE COIL DID NOT ENTER THE MICROCATHETER WHILE PERFORMING THE PROCEDURE IN ACCORDANCE WITH THE IFU. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9130315 ↗
• MalfunctionJul 24, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT TWO CONCERTO COILS DID NOT FUNCTION AS DESIRED. THE COILS WERE REPORTED TO HAVE BEEN "DEFECTIVE/ BROKEN". THE COILS WERE NOT USED TO TREAT THE PATIENT. NO ADDITIONAL EVENT DETAILS ARE KNOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8823381 ↗
• 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 8745945 ↗
• 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 8745931 ↗
• 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 REPORTED TO HAVE BEEN NORMAL. 2 TO 3 DETACH ATTEMPTS WERE MADE THE INSTANT DETACHER AND 2 TO 3 DETACHMENTS WERE MADE VIA THE MANUAL METHOD. ISSUES OCCURRED PRIOR TO THE DETACHMENT ATTEMPTS. NO DAMAGE WAS NOTED ON THE REMOVED PUSHWIRE. THE DEVICES WERE PREPARED AND USED PER THE IFU. ANCILLARY DEVICES INCLUDE A PROGREAT MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745737 ↗
• MalfunctionJun 3, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO OF THE NV-2-8-HELIXS WOULD NOT LOAD, AND A NV-2-6-HELIX WAS FRAYED. THE PATIENT UNDER WENT COILING TREATMENT OF Y90 MAPPING RIGHT HEPATIC. THE PATIENT'S BLOOD FLOW WAS NORMAL. THE VESSEL WAS NORMAL TORTUOUS. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED PER THE IFU. THE COIL WAS HYDRATED PER THE IFU. PROGREAT 2.8 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8663165 ↗
• MalfunctionJun 3, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO OF THE NV-2-8-HELIXS WOULD NOT LOAD, AND A NV-2-6-HELIX WAS FRAYED. THE PATIENT UNDER WENT COILING TREATMENT OF Y90 MAPPING RIGHT HEPATIC. THE PATIENT'S BLOOD FLOW WAS NORMAL. THE VESSEL WAS NORMAL TORTUOUS. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED PER THE IFU. THE COIL WAS HYDRATED PER THE IFU. PROGREAT 2.8 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8663154 ↗
• MalfunctionMay 30, 2019Break; Break

  MEDTRONIC RECEIVED A REPORT OF CONCERTO COIL BREAK. 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 8655875 ↗
• MalfunctionMay 13, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT 2 CONCERTO COILS FAILED TO DETACH WITH THE INSTANT DETACHER (ID). THE CONCERTO COIL FAILED TO DETACH. 3 TO 4 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER (ID). IT WAS ASKED IF A 2ND ID WAS USED AND IF MANUAL DETACHMENT WAS ATTEMPTED, BUT THIS INFORMATION WAS UNKNOWN. THE ID WAS DISCARDED AT THE SITE. THERE WERE NO ISSUES WITH ID. THIS EVENT WAS REPORTED TO HAVE OCCURRED A SECOND TIME WITH A REPLACEMENT CONCERTO COIL. THE REPORTED DEVICES AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CUSTOMER WAS NOTIFIED THAT THE DEVICES SHOULD BE RETURNED FOR ANALYSIS. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR, EXTRACRANIAL ARTERY ANEURYSM WITH A MAX DIAMETER OF 3.5MM, AND A NECK DIAMETER OF 1.2MM. THE BLOOD FLOW AND THE ANATOMY WERE REPORTED TO HAVE BEEN NORMAL. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8604180 ↗
• MalfunctionMay 13, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT 2 CONCERTO COILS FAILED TO DETACH WITH THE INSTANT DETACHER (ID). THE CONCERTO COIL FAILED TO DETACH. 3 TO 4 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER (ID). IT WAS ASKED IF A 2ND ID WAS USED AND IF MANUAL DETACHMENT WAS ATTEMPTED, BUT THIS INFORMATION WAS UNKNOWN. THE ID WAS DISCARDED AT THE SITE. THERE WERE NO ISSUES WITH ID. THIS EVENT WAS REPORTED TO HAVE OCCURRED A SECOND TIME WITH A REPLACEMENT CONCERTO COIL. THE REPORTED DEVICES AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CUSTOMER WAS NOTIFIED THAT THE DEVICES SHOULD BE RETURNED FOR ANALYSIS. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR, EXTRACRANIAL ARTERY ANEURYSM WITH A MAX DIAMETER OF 3.5MM, AND A NECK DIAMETER OF 1.2MM. THE BLOOD FLOW AND THE ANATOMY WERE REPORTED TO HAVE BEEN NORMAL. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8604172 ↗
• MalfunctionMay 2, 2019Activation Problem

  THE CONCERTO COIL SYSTEM COILED INSIDE THE MICROCATHETER AND FAILED TO DEPLOY. ANOTHER COIL WAS THEN USED; PROCEDURAL NOTE INDICATES: "COIL EMBOLIZATION OF THE SUPERIOR RECTAL ARTERY WAS THEN PERFORMED TO STASIS." THERE WERE NO COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8572745 ↗
• MalfunctionFeb 14, 2019Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE IMPLANT COIL SHOWED SOME DIFFICULTY PROGRESSING IN THE CATHETER AND EVENTUALLY RELEASED INSIDE THE CATHETER. THE PUSHWIRE REPORTEDLY HAD NOT BEEN ROTATED DURING DELIVERY OF THE COIL. IN ADDITION, THE PUSHWIRE WAS NOT OBSERVED TO BE BENT OR BROKEN. THE PHYSICIAN REMOVED THE DEVICE AND REPLACED IT WITH ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER PROBLEMS. NO INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THE EVENT. THE COIL HAD BEEN PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8341493 ↗
• MalfunctionDec 6, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT, THESE TWO COILS STUCK INSIDE THEIR INTRODUCER SHEATH. IT WAS REPORTED THAT FIST COIL WOULD NOT ABLE TO ADVANCE IN THE CATHETER HUB AS DID NOT COME OUT OF THE INTRODUCER SHEATH. ANOTHER SAME SIZE OF THE COIL WAS USED BUT HAD THE SAME ISSUE. THE PHYSICIAN USED DIFFERENT SIZE OF THE COILS AND PROCEDURE WAS COMPLETED. THE PATIENT IS DOING FINE. ALL DEVICES WERE USED PER THE IFU. .021 MICROCATHETER WAS USED BUT UNKNOWN MICROCATHETER AND HOSPITAL DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8138638 ↗
• MalfunctionOct 19, 2018Failure to Advance

  THE CONCERTO COIL WOULD NOT FEED THROUGH MICRO CATHETER. ANOTHER PACKAGE WAS OPENED AND USED AND THIS ONE WORKED WITHOUT ANY DIFFICULTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7983530 ↗