ConcertoTM NV-7-30-HELIX (UDI 00847536033580)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847536033580), received between Sep 25, 2019 and Oct 24, 2023 — classified as 2 injuries, 9 malfunctions.

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

• MalfunctionOct 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AS THE PHYSICIAN ADVANCED THE CONCERTO COIL PACK, HE PUSHED THE DETACHMENT ZONE OFF OF THE COIL INTO THE COIL PACK AND THE COIL DETACHED. THE PHYSICIAN SAID THIS WAS NOT A MALFUNCTION AND THE COIL WAS DETACHED DUE TO ADVANCING OF THE DETACHMENT ZONE AGAINST THE TIGHT COIL PACK. THE COIL REMAINED IMPLANTED AND THE PHYSICIAN LIKED THE PLACEMENT OF THE COIL AND THE PHYSICIAN WAS OVERALL HAPPY WITH THE RESULT. THE CONCERTO COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   THE PATIENT WAS UNDERGOING SURGERY FOR IMA EMBOLIZATION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996317 ↗
• InjuryJan 23, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING TWO CONCERTO COILS THAT FAILED TO DETACH. THE PATIENT WAS UNDERGOING GASTRODUODENAL ARTERY (GDA) TREATMENT. IT WAS REPORTED THAT THESE ARE THE 2 HELIX COILS THAT WE HAD ISSUES WITH. INEVITABLY THEY WERE BOTH DEPLOYED AND IMPLANTED IN THE PATIENT. AS WELL AS CHARGED TO THE PATIENT OF COURSE. THE COILS WERE PLACED IN THE GDA WITH A NON-TORTUOUS APPROACH. THE REBAR 18 WAS THE MICROCATHETER BEING USED. AT THE CLOSE OF THE CASE IT WAS NOTED THAT THE INTERNAL RELEASE WIRE REMAINED ATTACHED TO THE COIL AND PARTIALLY WITHIN THE AORTA. THE TECHS NOTED THAT THE CASE SEEMED TO GO AS NORMAL UNTIL THEY HAD ISSUES WITH THE 2 - 7 X 30 HELICAL COILS. THEY DID PLACE A NUMBER OF OTHER COILS WITHOUT DIFFICULTY. IT WAS REPORTED THAT NON-DETACHMENT OCCURRED. IT IS NOT STATED HOW MANY TIMES THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER. THE PHYSICIAN DID TRY TO DETACH WITH ANOTHER INSTANT DETACHER, BUT IT IS UNKNOWN HOW MANY TIMES THE SECOND INSTANT DETACHER WAS USED. IT IS UNKNOWN IF THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. IT WAS REPORTED THERE WAS NO ISSUE WITH THE INSTANT DETACHER.  THE REPORTED DEVICE AND ANY ACCESSORY DEVIC

  Patient problems: Foreign Body In Patient

  MAUDE report 16223914 ↗
• MalfunctionNov 19, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS STUCK IN THE SHEATH. A LOOP WAS NOT MADE AND THE COIL DIDN'T ADVANCE. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANEURYSM. ANCILLARY DEVICES INCLUDE A PROGREAT 2.4F MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS NOT KNOWN. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15830418 ↗
• MalfunctionNov 8, 2022Break; Material Deformation; Break; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. ANOTHER TECH REPORTED AFTER THE CASE THAT IT DID SEEM AS IF THERE WAS A KINK IN THE PUSHER WIRE. TWO COILS HAD ALREADY BEEN IMPLANTED BEFORE, AND THIS WAS THE LAST COIL. THEY WERE ABLE TO PUSH THE COIL OUT SO THEY DID NOT REMOVE IT. THE CAUSE OF THE BREAK WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751921 ↗
• MalfunctionSep 12, 2022Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION THAT 3 CONCERTO COILS HAD COMPACTION. OCCURRED ACCORDING TO THIS FOLLOW UP FORM. ASSESSMENT ABOUT RELATEDNESS. NO ADVERSE EVENT OR DEVICE DEFICIENCY REPORTED. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407747 ↗
• MalfunctionAug 25, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COILS EXPERIENCED RESISTANCE IN THE PROXIMAL PART OF THE MICROCATHETER AND ONE PREMATURELY DETACHED DURING REMOVAL. THE PATIENT WAS UNDERGOING TREATMENT FOR GI BLEED EMBOLIZATION. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT FIRST 5X15 COIL WAS DEPLOYED AS AN ANCHOR. ANOTHER 5X20 WAS USED, BUT IT JAMMED IMMEDIATELY IN THE MICROCATHETER. THEY UPSIZED AND USED 2 7X30 COILS SUCCESSFULLY. A THIRD 7X30 COIL JAMMED IN THE MICROCATHETER AND DETACHED WHEN THE DOCTOR PULLED THE INTRODUCER SHEATH BACK TO SEE IF THE COIL WAS IN THE MICROCATHETER OR JAMMING IN THE HUB. THE COIL WAS PULLED OUT OF THE CATHETER HUB WITH NO FURTHER MEDICAL/SURGICAL INTERVENTION REQUIRED. ALL COILS WERE DIPPED IN SALINE AND THEN SHEATHED BEFORE IMPLANTING. WHEN THE COILS JAMMED THEY WERE RESHEATHED AND RE-DIPPED IN THE SALINE. THEN THEY WERE TRIED AGAIN BUT JAMMED. THE PUSHWIRE WAS NOT BEND OR BROKEN, THE PHYSICIAN DID NOT REPOSITION THE COIL, NO DETACHMENT ATTEMPTS HAD BEEN MADE, THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER, AND A CONTINUOUS FLUSH WAS NOT ADMINISTERED. THE COILS HAD PUSHED OUT OF THE INTRODUCER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298701 ↗
• MalfunctionMay 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL INADVERTENTLY DETACHED WHEN PULLING IT BACK INTO THE CATHETER FROM THE VESSEL. THE COIL REMAINED IN THE PATIENT, BUT IT WAS UNKNOWN IF IT WAS IMPLANTED AT THE INTENDED LOCATION. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE COIL HAD BEEN REPOSITIONED, AND NO DETACHMENT ATTEMPTS WERE MADE. THE PATIENT WAS UNDERGOING TREATMENT FOR A SPLENIC ARTERY ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454924 ↗
• MalfunctionDec 10, 2021Stretched; Separation Failure; Material Deformation; Physical Resistance/Sticking; Stretched; Separation Failure; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DOCTOR TRIED TO DEPLOY THE CONCERTO COIL WITHOUT USING THE INSTANT DETACHER, BUT IT COULD NOT BE DEPLOYED. THE COIL WAS FOUND TO BE STRETCHED AND ELONGATED. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. A CONTINUOUS FLUSH WAS NOT ADMINISTERED, AND THE PUSHWIRE DISTAL SEGMENT WAS DAMAGED/STRETCHED. THE COIL HAD NOT BEEN REPOSITIONED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS BEING USED FOR A DEMO AND WAS NOT USED IN A PATIENT. THE DOCTOR TRIED TO USE THE COIL IN A PIG LUNG MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12978912 ↗
• MalfunctionNov 17, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT 3 ATTEMPTS WERE MADE TO DETACH THE COIL USING THE INSTANT DETACHER. 2-3 ATTEMPTS WERE MADE TO DETACH THE COIL USING THE MANUAL METHOD. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO COIL NON-DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12831318 ↗
• MalfunctionJul 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL THAT DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED AMORPHOUS ANEURYSM OF THE RIGHT COMMON ILIAC ARTERY. IT WAS NOTED THAT THE ARTERY WAS HAVING EMBOLISMS PRIOR TO THE PROCEDURE. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THE CONCERTO COIL AND THE ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). WHEN THE COIL WAS BEING ADVANCED INTO THE MICROCATHETER, IT BECAME DETACHED. NO FRICTION HAD BEEN NOTED DURING DELIVERY. NO ATTEMPTS AT DETACHMENT HAD BEEN MADE. THE PHYSICIAN DID NOT ROTATE THE PUSHER. CONTINUOUS CATHETER FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE COIL WAS SAFELY REMOVED FROM THE MICROCATHETER AND WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICE: PROGREAT 2.7FR MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12143055 ↗
• InjurySep 25, 2019Migration; Migration

  MEDTRONIC RECEIVED REPORT THAT THE 2 CONCERTO COIL MIGRATED AND REQUIRED INTERVENTION. DURING THE COMPLETING OF AN EMBOLIZATION OF A VARICOCELE. THE VARICOCELE WAS TREATED WITH A COMBINATION OF COILS AND SCLEROSANT. A CONCERTO 4X10 WAS PLACED, FOLLOWED BY 7X30, INJECTED SCLEROSANT THEN WENT TO CAP THE TOP OF THE GONADAL BELOW THE RENAL ORIGIN WITH A 7X30 AND EMBEDDED A 4X10 TO CREATE A DENSE PACK AT THE TOP. THE INITIAL VISUAL RESULT LOOKED GOOD. A SLIGHT PUFF OF CONTRAST WAS PERFORMED AND LOOKED GOOD. THE CATHETER WAS BACK TO DO A MORE POWERFUL INJECTION AS A FINAL RUN. UPON INJECTING, THE LAST 2 COILS SHOT UP AND OUT OF THE GONADAL VEIN FLOWING INTO THE RENAL VEIN. THE 4X10 COIL SAT AT THE RENAL ORIGIN OFF OF THE INFERIOR VENA CAVA (IVC) FOR A MOMENT AND THEN SHOT UP TO THE LUNGS. THE 7X30 WAS STRUNG OUT AND HANGING HALF IN THE GONADAL AND HALF IN THE RENAL. THE CONCERTO COIL 7X30 WAS SNARED OUT QUICKLY. ATTEMPTS WERE MADE TO SNARE THE 4X10 CONCERTO COIL OUT OF THE LUNG. AN HOUR PLUS WITHOUT SUCCESS. THE VARICOCELE EMBOLIZATION WAS THEN COMPLETED WITH 7X30 (A541620). THEN ATTEMPTS TO REMOVE THE 4X10 COIL FROM THE LUNG WERE RESUMED. VARIETY OF TECHNIQUES WERE USED AND FINALLY WAS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9119471 ↗