ConcertoTM PV-12-30-HELIX (UDI 00847536033627)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847536033627), received between Oct 29, 2020 and May 3, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS COIL NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 10 TIMES. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER 5 TIMES. THERE WERE NO MANUAL ATTEMPTS TO DETACH VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED SPLENIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 14MM AND A 8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239421 ↗
• MalfunctionDec 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS BEING USED AS PER THE IFU BUT THE COIL COULD NOT BE INSERTED INTO THE MICROCATHETER. A NEW MEDTRONIC PRODUCT USED TO COMPLETE THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER WAS NOT A MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18351742 ↗
• MalfunctionOct 25, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE DETACHED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004716 ↗
• MalfunctionOct 24, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE DETACHED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998332 ↗
• MalfunctionApr 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED BY TAKING OUT THE MICROCATHETER AND REMOVING THE COIL/PUSHER AND ANOTHER CONCERTO WAS USED. MANUAL DETACHMENT WAS TRIED 1 TIME. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823689 ↗
• MalfunctionFeb 17, 2023Stretched; Material Deformation; Stretched; Material Deformation

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE PUSHWIRE WAS DAMAGED AT THE START TO MIDDLE SEGMENT, AND ALSO THE COIL BODY WAS STRETCHED AND ELONGATED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16399388 ↗
• MalfunctionNov 3, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL PUSHWIRE WAS STUCK IN THE INSTANT DETACHER (ID). THE PATIENT WAS UNDERGOING AN OVARIAN VEIN COIL EMBOLIZATION PROCEDURE. THE COIL WAS SUCCESSFULLY DETACHED AND IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722236 ↗
• MalfunctionSep 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL PREMATURELY DETACHED DURING APPROACH TO THE MICROCATHETER. THE DEVICE WAS REPLACED, AND THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432423 ↗
• MalfunctionJun 7, 2022Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL EXPERIENCED RESISTANCE IN THE SHEATH AND HAD A PART DISLODGE. THE PATIENT WAS UNDERGOING TREATMENT FOR COIL EMBOLIZATION FOR SPLENIC ARTERY BLEEDING. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THERE WAS NO DEGREE OF CALCIFICATION. THE ARTERY WAS 7MM IN DIAMETER. IT WAS REPORTED THAT DURING REMOVAL OF THE COIL FROM THE LOOP, THERE WERE ONE LONG AND ONE SHORT BLACK MARKER AT THE END OF THE PUSHER. WHEN THE COIL WAS DELIVERED INTO THE PATIENT AND THE PLASTIC COVERING WAS TO BE TAKEN OUT IT GOT STUCK AND THE COILS WERE ALREADY IN PLACE. THE DOCTOR PULLED FORCEFULLY TO REMOVE THE PLASTIC COVERING TO EXPOSE THE REMAINDER OF THE COIL PUSHER. THEY WERE UNABLE TO FIND THE SHORT BLACK MARKER WHICH IS USED FOR HAND DEPLOYMENT. THE PROCEDURE WAS COMPLETED BY BREAKING THE LONGER BLACK MARKER AND THE COIL WAS SUCCESSFULLY DEPLOYED. THE COIL HAD BEEN PREPARED WITH NO ISSUE. IT WAS NOTICED THAT THERE WERE VERY DARK MARKINGS INSIDE THE PLASTIC SHEATH. IT WAS POSSIBLE THE SHORT BLACK MARKER GOT DISLODGED AND GOT PUSHED TO THE LONG BLACK MARKER AND GOT STUCK. THE PLASTIC SHEATH HAS SMALL TOLERANCE, AND RESISTANCE WAS FELT WHEN REMOVING THE PLASTIC SHEATH. 

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628239 ↗
• MalfunctionMar 3, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT A CONCERTO COIL THAT FAILED TO DETACH EVENT WHEN THE PHYSICIAN ATTEMPTED MANUAL DETACHMENT. IT WAS NOTED THAT THE COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE. VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13662952 ↗
• MalfunctionSep 14, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COIL COULD NOT PASS THE CATHETER. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) INDICATED IT WAS UNKNOWN IF THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK OR DAMAGE OBSERVED TO THE COIL AFTER REMOVAL. A TERUMO CATHETER WAS USED, BUT THE MODEL WAS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12472054 ↗
• MalfunctionMar 27, 2021Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL AND PUSHWIRE WAS NOT DAMAGED. IT TOOK THE DOCTOR APPROXIMATELY AN HOUR TO MANUALLY PUSH THE DETACHED COIL INTO THE PATIENT. THERE WERE NO ATTEMPTS MADE TO DETACH THE COIL; IT DETACHED IN THE CATHETER PRIOR TO REACHING THE DESIRE LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579818 ↗
• MalfunctionOct 29, 2020Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10757926 ↗