Concerto Detachable Coil System PV-3-8-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847536045125), received between Oct 10, 2024 and Sep 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (10 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.

• MalfunctionSep 30, 2026Physical Resistance/Sticking

  Medtronic received a report about a delivery wire getting stuck during in an instant detacher. The coil deployed successfully and no patient complications were associated with this event. Additional information was received reporting that the patient was undergoing treatment for an aortopulmonary collateral. The patient vessel tortuosity was moderate. No causes or contributing factors for the resistance were identified. The information has been confirmed/provided by the physician.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947629 ↗
• MalfunctionAug 6, 2026Detachment of Device or Device Component; Compatibility Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161291 ↗
• MalfunctionJan 26, 2026Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE EVENT WAS THE COIL COULD NOT GET INTO THE MICROCATHETER. THE PROCEDURE WAS BRONCHIAL ARTERIAL EMBOLIZATION (BAE), NOT BRAIN ARTERIOVENOUS EMBOLIZATION. PRIOR TO COIL NON-DETACHMENT , THE COIL COULD NOT GET INTO THE MICROCATHETER. THERE WAS KINKING FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184275 ↗
• MalfunctionJan 9, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THREE CONCERTO HELIX COILS (N=1 NV-2-8-HELIX, N=2 NV-3-8-HELIX) AND ONE CONCERTO 3D COIL (PV-3-8-3D) MET RESISTANCE\BECAME STUCK IN THE PROXIMAL END OF A NON-MEDTRONIC MICROCATHETER AND WERE UNABLE TO BE ADVANCED. THE IMPLANT COILS PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH AND THERE WAS NO DAMAGE TO THE COILS OR THE CATHETER. ADDITIONALLY, A CONCERTO HELIX COIL (NV-6-20-HELIX) MET RESISTANCE FROM THE POINT OF INITIAL ADVANCEMENT THROUGH THE SAME NON-MEDTRONIC MICROCATHETER AND WAS UNABLE TO BE ADVANCED PAST THE MIDDLE SECTION OF THE MICROCATHETER. UPON REMOVAL OF THE COIL, IT WAS OBSERVED THAT THE MIDDLE SEGMENT OF THE DELIVERY PUSHWIRE WAS KINKED. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE SAME MICROCATHETER WAS USED TO FINISH THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN ENDOLEAK. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED TRUSELECT¿ MICROCATHETER. ADDITIONAL INFORM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020345 ↗
• MalfunctionJul 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT TWO CONCERTO COILS RESISTANCE AND WERE STUCK IN THE SHEATH PRIOR TO USE. IT WAS ATTEMPTED TO PUSH THE COIL OUT FROM THE ORIGINAL PROTECTION TRANSPARENT SHEATH, BUT IT WAS IMPOSSIBLE TO MOVE IT FORWARD FROM THE SHEATH. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL WAS FOUND TO BE STUCK IN THE PROTECTIVE SHEATH UPON THE FIRST ATTEMPT TO ADVANCE THE COIL FROM THE SHEATH. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD HORIZONTALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. A CONTINUOUS SALINE FLUSH WAS NOT ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591710 ↗
• MalfunctionJul 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT TWO CONCERTO COILS RESISTANCE AND WERE STUCK IN THE SHEATH PRIOR TO USE. IT WAS ATTEMPTED TO PUSH THE COIL OUT FROM THE ORIGINAL PROTECTION TRANSPARENT SHEATH, BUT IT WAS IMPOSSIBLE TO MOVE IT FORWARD FROM THE SHEATH. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL WAS FOUND TO BE STUCK IN THE PROTECTIVE SHEATH UPON THE FIRST ATTEMPT TO ADVANCE THE COIL FROM THE SHEATH. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD HORIZONTALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. A CONTINUOUS SALINE FLUSH WAS NOT ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591444 ↗
• MalfunctionMay 5, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE COIL NON-DETACHMENT COULD NOT BE DETERMINED. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER THE COIL WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961633 ↗
• MalfunctionMar 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL THAT HAD RESISTANCE/WAS STUCK IN THE NON-MEDTRONIC CATHETER. IT WAS REPORTED THAT CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE, WHICH CAUSED THE CONCERTO COIL TO GET STUCK DURING DELIVERY IN THE CATHETER. THE COIL WAS REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. IT WAS NOTED THAT THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. IT WAS ALSO NOTED THAT THE DEVICE WAS NOT PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AS CONTINUOUS FLUSH WAS NOT ADMINISTERED. NO PATIENT INFORMATION WAS REPORTED. ANCILLARY DEVICE: PROGREAT 2.7 CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594994 ↗
• MalfunctionNov 8, 2024Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THEY REPLACED THE COIL TO ANOTHER COMPANY'S COIL TO RESOLVE THE COIL RESISTANCE/NON-DETACHMENT. THE CAUSE OF THE COIL RESISTANCE/NON-DETACHMENT WAS NOT DETERMINED. THE CATHETER RESISTANCE WAS IN THE DISTAL SECTION. THE COIL DID COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT. THEY DIDN'T TRY TO DETACH THE COIL BECAUSE THE COIL STUCK INSIDE THE CATHETER. THEY DON¿T USE INSTANT DETACHER, ONLY DETACHMENT BY HAND. THE COIL STUCK IN THE CATHETER, SO NO DETACHMENT HAPPENED. THE PROCEDURE WAS WITH NO PROBLEM AT ALL. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640389 ↗
• MalfunctionNov 8, 2024Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THEY REPLACED THE COIL TO ANOTHER COMPANY'S COIL TO RESOLVE THE COIL RESISTANCE/NON-DETACHMENT. THE CAUSE OF THE COIL RESISTANCE/NON-DETACHMENT WAS NOT DETERMINED. THE CATHETER RESISTANCE WAS IN THE DISTAL SECTION. THE COIL DID COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT. THEY DIDN¿T TRY TO DETACH THE COIL BECAUSE THE COIL STUCK INSIDE THE CATHETER. THEY DON¿T USE INSTANT DETACHER, ONLY DETACHMENT BY HAND. THE COIL STUCK IN THE CATHETER, SO NO DETACHMENT HAPPENED. THE PROCEDURE WAS WITH NO PROBLEM AT ALL. NO PUSHWIRE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640379 ↗
• MalfunctionOct 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THREE DIFFERENT SIZED CONCERTO COILS COULD NOT BE INTRODUCED THROUGH A 2.4F MICROCATHETER EVEN THOUGH THERE WAS A Y-ADAPTER AND FLUSHING WAS MADE PROPERLY. THEY NEEDED TO TAKE A NEW COIL FOR EACH SIZE TO COMPLETE THE INTERVENTION. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE CATHETER. IT WAS REPORTED THE CONCERTO COILS DID NOT GO THROUGH THE MICROCATHETER. PATIENT WAS UN-INJURED. 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. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. 2024-JUL-22 E1 (FOR, REP, HCP): NO NEW EVENT INFORMATION RECEIVED. 2024-JUL-23 EMAIL X2 (FOR, REP, HCP): ADDITIONAL INFORMATION RECEIVED REPORTED THAT A NEW COIL HAD TO BE OPENED AT A TIME. A SERIOUS CONSEQUENCE DID NOT ACTUALLY ARISE FOR THE PATIENT, USER OR THIRD PARTY. A POSSIBLE SERIOUS CONSEQUENCE NOTED WAS A DELAY OF THE PROCEDURE. 2024-AUG-12 E2, E3, E4 (FOR, REP, HCP): NO NEW EVENT INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 20422339 ↗