Concerto Detachable Coil System PV-6-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536045163), received between May 16, 2024 and Nov 6, 2025 — classified as 5 malfunctions.

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

• MalfunctionNov 6, 2025Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL HAD SOME RESISTANCE DURING INSERTION IN THE MICROCATHETER. THE MICROCATHETER WAS NOT A MEDTRONIC DEVICE. WHEN THE COIL WAS WITHDRAWN, IT WAS NOTED THE THE WIRE WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490194 ↗
• MalfunctionJun 9, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS A FAILURE TO RELEASE THE SPRING AT THE TIME OF SURGERY. THE DEVICE WAS REMOVED FROM THE PATIENT AND A NEW SPRING WAS INSTALLED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170367 ↗
• MalfunctionJan 31, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT TWO CONCERTO COILS BECAME STUCK IN THE CATHETER. THE SPECIFIC LOCATION WITHIN THE CATHETER WHERE THE RESISTANCE WAS ENCOUNTERED IS UNKNOWN, AND IT IS NOT SPECIFIED WHETHER THE CATHETER OR COILS WERE DAMAGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN WHAT CATHETER WAS USED, BUT IT WAS NOT A MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283084 ↗
• MalfunctionMay 17, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE ADVANCED IN ATTEMPTS TO USE IT. 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 19343958 ↗
• MalfunctionMay 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE ADVANCED IN ATTEMPTS TO USE IT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETED WITH A NEW PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336620 ↗