ConcertoTM NV-8-30-HELIX (UDI 00847536013704)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536013704), received between Nov 7, 2018 and Jul 31, 2023 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING CONCERTO COIL WITH NO DETAILS REGARDING THE EVENT. THERE WAS NO ALLEGED PRODUCT ISSUE, BUT IT WAS NOTED THAT THE REP WILL FOLLOW UP WITH THE HEALTHCARE PROFESSIONAL REGARDING THE EVENT. THE DEVICE WAS REPLACED WITH ANOTHER MEDTRONIC DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE CONCERTO COIL EXPERIENCED RESISTANCE WITH THE PROGREAT 2.7FR. THE COIL WAS UNABLE TO EXIT THE CATHETER. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430667 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT BEGAN EXPERIENCING SYMPTOMS TWO WEEKS AFTER BEING IMPLANTED WITH CONCERTO COILS. THEY INITIALLY EXPERIENCED NEEDLES AND PINS IN THEIR FEET AND SEVERE PAINS, SWELLING AND REDNESS IN DIFFERENT AREAS OF THEIR BODY. THEIR QUALITY OF LIFE WAS SEVERELY IMPACTED. THEY UNDERWENT MULTIPLE DIFFERENT TEST TO IDENTIFY REASONS FOR THIS PROBLEM AND AFTER 2 YEARS THEY SAID THE COILS MIGHT BE CAUSING AN ALLERGIC REACTION. THERE WERE NO MALFUNCTIONS WITH THE DEVICE, AND THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR VARICOCELE. ADDITIONAL INFORMATION RECEIVED REPORTED ALLERGY TO THE CONCERTO COILS WAS ONLY CONSIDERED AFTER 2 YEARS OF TESTING. THE PATIENT UNDERWENT SEVERAL SCANS, ARTHRITIC TREATMENTS, AND ALLERGY TESTS. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT SAW SEVERAL DOCTOR AND WAS HOSPITALIZED TO ADDRESS THE PAIN RELATED TO THE EVENT. THE EVENTS WERE NOT CONSIDERED LIFE-THREATENING BUT WERE NOTED TO BE DETRIMENTAL TO THE PATIENT'S QUALITY OF LIFE. THE PATIENT CONTINUES TO HAVE SYMPTOMS. REFER TO MANUFACTURER REPORT 2029214-2021-01043 FOR DETAILS PERTAINING TO THE RELATED RE

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Pain; Paresthesia; Swelling/ Edema

  MAUDE report 12348845 ↗
• MalfunctionOct 27, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES PRIOR TO DETACHMENT, AND THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10741052 ↗
• MalfunctionJun 26, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT DETACHMENT WITH THE INSTANT DETACHER WAS ATTEMPTED ONLY ONCE. PRIOR TO NON-DETACHMENT, THERE WERE NO ISSUES OR DIFFICULTIES IN THE PROCEDURE. THERE WAS NO OBSERVED DAMAGE TO THE PUSHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10204059 ↗
• MalfunctionMay 6, 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 INSPECTED AND PREPARED ACCORDING TO THE MANUFACTURER INSTRUCTIONS FOR USE WITH NO ISSUE IDENTIFIED. THE COIL DETACHED DURING THE PROCEDURE BEFORE THE INSTANT DETACHED WAS USED. THE PHYSICIAN USED A SNARE TO SUCCESSFULLY REMOVE THE COIL AND IT WAS REPLACED. THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10029416 ↗
• MalfunctionApr 30, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THREE COILS FAILED TO DEPLOY. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A TYPE II ENDOLEAK AFTER EVAR PROCEDURE. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE VESSEL TORTUOSITY WAS UNKNOWN. NO PATIENT INJURY WAS REPORTED. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. REBAR 027 MICROCATHETER ¿ HOSPITAL DISCARDED ALL THE COMPLAINT GOODS DUE TO THE CONCERN OF SPREAD OF CORONAVIRUS. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE COIL WAS STILL ATTACHED WHEN SHOWN UNDERX-RAY FOR 3 COILS. THERE WAS NO RESISTANCE FELT IN THE CATHETER. A CONTINUOUS FLUSH WAS NOT USED, BUT THE CATHETER WAS FLUSHED PRIOR TO THE COIL ENTERING. THE PROCEDURE WAS COMPLETED USING REPLACEMENT COILS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10014569 ↗
• MalfunctionApr 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF AXIUM PREMATURE DETACHMENT DURING A PROCEDURE. THE COIL WAS REPORTED TO BE "CUT OFF". IT IS NOT KNOWN WHEN DURING THE PROCEDURE THE COIL SEPARATED FROM THE PUSHWIRE. NO DETACHMENT ATTEMPTS WERE MADE. THE COIL WAS REPORTEDLY PREPARED AND FLUSHED AS INDICATED IN THE IFU. THE PROCEDURE TYPE AND VESSEL TORTUOSITY WAS NOT KNOWN. THERE WERE REPORTEDLY NO INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9959773 ↗
• MalfunctionFeb 28, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WOULD NOT DETACH WITH THE INSTANT DETACHER. ONE ATTEMPT WAS MADE, ANOTHER INSTANT DETACHER WAS NOT USED, ONE MANUAL ATTEMPT WAS MADE. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A GI BLEED. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9771212 ↗
• MalfunctionAug 5, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT COIL BROKE OFF WHEN IT WAS ATTEMPTED TO BE RECAPTURED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NOT ANY FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT RE-POSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. THE COIL REMAINS IN THE PATIENT AND IMPLANTED AT THE INTENDED LOCATION. THE PATIENT WAS UNDERGOING EMBOLIZATION FOR A GIANT FUSIFORM SPLENIC ARTERY ANEURYSM, MEASURING 22MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL. THE VESSEL WAS SEVERELY TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8862886 ↗
• MalfunctionJun 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THESE ALL COIL COULD NOT PASS THE MICROCATHETER HUB. THE PHYSICIAN FOLLOWED BY THE IFU. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO PATIENT INJURY WAS REPORTED. DETAILED INFORMATION ABOUT THE PATIENT AND DEVICES USED WERE NOT AVAILABLE DUE TO A HOSPITAL POLICY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8741910 ↗
• MalfunctionDec 7, 2018Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT LOOP DURING DEPLOYMENT. IT WAS STATED THAT THE COIL MIGRATED FROM THE SITE OF DEPLOYMENT AND HENCE COULD NOT ACHIEVE THE TARGET VESSEL EMBOLIZATION. THE PHYSICIAN TRIED MULTIPLE TIMES, BUT IT WAS NOT FORMING ANY LOOP. THE COIL WAS REPLACED, AND THE ANOTHER COIL WAS IMPLANTED IN THE INTENDED LOCATION. THE PATIENT WAS UNDERGOING TREATMENT FOR A SPLENIC ARTERY EMBOLIZATION. IT WAS NOTED THE VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THEEVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICE: PROGREAT MICROCATHETER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8143424 ↗
• InjuryNov 7, 2018Break; Break

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE COIL WAS ABOUT HALFWAY OUT IT KICKED THE MICROCATHETER OUT OF PLACE DUE TO RESISTANCE/BEING STUCK. THE PHYSICIAN ATTEMPTED TO PULL THE COIL BACK INTO THE MICROCATHETER BUT IT BROKE, WITH PART OF THE COIL GOING INTO THE LEFT HEPATIC AND UNABLE TO BE RETRIEVED. IT WAS NOTED THAT THE COIL APPARENTLY DEPLOYED IN THE BODY. PRIOR TO THE ISSUE TWO COILS HAD BEEN PLACED SUCCESSFULLY WITHOUT ISSUE. IT WAS GUESSED BY THE MANUFACTURER REPRESENTATIVE (REP) THAT THE COIL MAY HAVE STRETCHED AND RELEASED. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE AND THEIR BLOOD FLOW WAS NORMAL. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU; HOWEVER, A CONTINUOUS FLUSH WAS NOT USED. THERE WAS NO ATTEMPT TO REPOSITION OR DETACH THE COIL. ANCILLARY DEVICES INCLUDE A BSCI HIGH FLOW GUIDE CATHETER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8046962 ↗