Concerto Detachable Coil System PV-16-40-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00847536045040), received between Aug 23, 2023 and Feb 18, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS COMPLETED BY OPENING MORE COILS AND PROCEDING. THE DAMAGE WAS NOTICED WHEN IT WAS REMOVED FROM THE PACKAGE PULLED FROM THE HOOP. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. COIL WAS NOT USED AND DID NOT ENTER THE BODY.THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403622 ↗
• MalfunctionFeb 18, 2025Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS COMPLETED BY OPENING MORE COILS AND PROCEDING. THE DAMAGE WAS NOTICED WHEN IT WAS REMOVED FROM THE PACKAGE PULLED FROM THE HOOP. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE¿PUSHWIRE WAS¿SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE¿PACKAGE WAS¿OPENED. COIL WAS NOT USED AND DID NOT ENTER THE BODY.THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21403109 ↗
• MalfunctionDec 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A GONADAL EMBOLIZATION PROCEDURE USING A CONCERTO HELIX COIL, THERE WERE ISSUES WITH COIL PREMATURE DETACHMENT, AND THE COIL WAS RELEASED INSIDE THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL THREE TIMES BUT WAS UNABLE TO CONFIGURE IT INSIDE THE VESSEL. CONSEQUENTLY, THE MICROCATHETER ALONG WITH THE COIL WAS REMOVED AND REPLACED WITH A COIL FROM ANOTHER BRAND. THE PUSHWIRE WAS NOT BENT OR BROKEN, THERE WAS NO FRICTION DURING DELIVERY. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL AND DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS FROM THIS EVENT AND NO MEDICAL INTERVENTION WAS REQUIRED. THE DEVICE WAS PREPARED PER IFU. THE PATIENT WAS BEING TREATED FOR GONADAL EMBOLIZATION. BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDED A REBAR CATHETER (MODEL: CFN 105-5083-153, LOT: B605632).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026691 ↗
• MalfunctionSep 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE ADVANCED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201354 ↗
• MalfunctionJul 16, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT TWO CONCERTO COIL COULD NOT BE DETACHED. IT WAS NOTED THAT THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COILS WERE NOT IMPLANTED AND WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY. ANCILLARY DEVICE: PROGREAT 2.4 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19748928 ↗
• MalfunctionMay 22, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT BOTH COILS WERE 20X50. THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373964 ↗
• MalfunctionMay 6, 2024Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT A COIL PUSHWIRE BROKE OFF IN THE INSTANT DETACHER (ID) DURING DEPLOYMENT OF THE THE COIL SO THE ID WAS REPLACED; THE COIL DETACHED SUCCESSFULLY. DURING THE SAME PROCEDURE, ANOTHER COIL WAS BENT BY THE SURGEON DURING DELIVERY. THE CONCERTO COIL WAS BEING WITHDRAWN BUT DETACHED INSIDE THE MICROCATHETER SO BOTH THE CATHETER AND COIL WERE WITHDRAWN FROM THE PATIENT'S BODY TOGETHER. IT WAS NOTED THAT THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU) HOWEVER, CONTINUOUS CATHETER FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THERE HAD BEEN FRICTION DURING DELIVERY OF THE COIL BUT THE SURGEON HAD NOT ATTEMPTED TO REPOSITION OR DETACH THE COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SEVERAL OTHER COILS AND NO OTHER ISSUES REPORTED. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING AN OVARIAN VEIN EMBOLIZATION PROCEDURE. PATIENT VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249512 ↗
• MalfunctionApr 29, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT RECOVERING FROM THE PROCEDURE FINE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THERE ARE NO PROCEDURAL / POST-PROCEDURAL IMAGING (CT,ANGIO, ETC.) AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202714 ↗
• MalfunctionApr 24, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. PRIOR TO COIL NON-DETACHMENT, NO ISSUES ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172345 ↗
• MalfunctionAug 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DETACHED WHILE RESHEATHING FROM THE SALINE BOWL ON THE BACK TABLE. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS UNINTENTIONALLY BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL AND DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. 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. THE PATIENT WAS UNDERGOING PRE-FONTAN TREATMENT. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17605517 ↗