ConcertoTM NV-2-4-HELIX (UDI 00847536013308)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847536013308), received between Dec 11, 2018 and Nov 24, 2020 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS BEING USED PER THE INSTRUCTIONS FOR USE (IFU), BUT WAS NOT VISIBLE ON THE ANGIOGRAPHY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897948 ↗
• MalfunctionOct 9, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COILS FAILED TO DETACH USING THE INSTANT DETACHER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A GI BLEED. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT ONE OF THE 2X4 CONCERTO COILS WOULD NOT DETACH WITH THE INSTANT DETACHER OR MANUALLY. THE SECOND COIL WOULD NOT DETACH WITH THE INSTANT DETACHER, BUT IT DID DETACH MANUALLY. THE INSTANT DETACHER WAS USED TWICE, AND A SECOND DETACHER WAS NOT USED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT ISSUE. THE COILS PUSHED OUT SMOOTHLY. THE WIRE WAS NOT KINKED/BENT BEFORE THE ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10659517 ↗
• MalfunctionJul 13, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COILS FAILED TO DETACH USING THE INSTANT DETACHER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A GI BLEED. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT ONE OF THE 2X4 CONCERTO COILS WOULD NOT DETACH WITH THE INSTANT DETACHER OR MANUALLY. THE SECOND COIL WOULD NOT DETACH WITH THE INSTANT DETACHER, BUT IT DID DETACH MANUALLY. THE INSTANT DETACHER WAS USED TWICE, AND A SECOND DETACHER WAS NOT USED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10264564 ↗
• 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 10186992 ↗
• InjuryFeb 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL UNINTENTIONALLY DETACHED. THE CONCERTO COIL WAS PUSHED OUT AND EMBOLIZED MORE PROXIMAL THAN THE AREA TARGETED. THERE WAS NO FRICTION FELT. THE COIL WAS NOT REPOSITIONED AND WAS NOT ATTEMPTED TO BE DETACHED BY THE USER. THE PUSHWIRE WAS NOT ROTATED. A CONTINUOUS FLUSH WAS USED. THE PATIENT¿S BLOOD FLOW AND VESSEL ANATOMY WERE BOTH NORMAL. THE PATIENT WAS ASYMPTOMATIC POST THE PROCEDURE. NO MEDICAL INTERVENTION WAS REQUIRED. THIS EVENT OCCURRED DURING THE TREATMENT OF A GASTROINTESTINAL (GI) BLEED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9708347 ↗
• MalfunctionOct 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT OF A CONCERTO COIL ¿DEPLOYED IN CATHETER AND NOT IN VESSEL¿ AND ¿UNRAVELED INSIDE MICRO CATHETER¿. NO SPECIFIC DETAILS PROVIDED. NO PATIENT INJURY REPORTED. NO INFORMATION WAS PROVIDED REGARDING THE MODEL OF THE MICROCATHETER. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USED. NO OTHER DETAILS WERE PROVIDED BY THE FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9153028 ↗
• MalfunctionJul 24, 2019Separation Failure; Separation Failure

  A MANUAL DETACHMENT METHOD WAS ATTEMPTED TWICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8823739 ↗
• MalfunctionJul 12, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE CONCERTO COIL WAS BLOCKED (STUCK) INSIDE THE MICROCATHETER AND IT COULD NOT BE DEPLOYED. THE COIL WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE COIL WAS NOT DAMAGED AND HAD NON-DETACHMENT. THE NUMBER OF ATTEMPTS TO DETACH THE COIL WITH THE INSTANT DETACHER WAS UNKNOWN AND USE OF THE MANUAL METHOD (BREAKING OF THE HYPOTUBE, AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE) WAS ALSO UNKNOWN. THE INSTANT DETACHER WAS DISCARDED. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. ANCILLARY DEVICE: MAESTRO MERIT MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8785440 ↗
• 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 8745700 ↗
• MalfunctionJun 10, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THIS COIL DID NOT DEPLOY DURING TREATMENT. THERE WASN'T MUCH INFORMATION GIVEN ABOUT THE ISSUES. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE VESSEL WAS MODERATELY TORTUOUS. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS PREPPED PER THE IFU. EVALUATION OF THE RETURNED DEVICE FOUND THAT THE IMPLANT COIL WAS DETACHED AND MISSING FROM THE PUSHWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8684880 ↗
• MalfunctionDec 11, 2018Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PUSHER WIRE BROKE AT THE DISTAL SEGMENT WHEN ATTEMPTING TO DEPLOY IT INTO THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A "BLEED." IT WAS NOTED THAT A CONTINUOUS FLUSH WAS NOT USED DURING THE PROCEDURE. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8152367 ↗