Concerto Detachable Coil System PV-12-40-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536045316), received between Jun 30, 2023 and Sep 25, 2026 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906181 ↗
• MalfunctionAug 17, 2026Use of Device Problem; Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50272760 ↗
• MalfunctionJul 10, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25784963 ↗
• MalfunctionApr 27, 2026Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WAS TREATED FOR AN UNRUPTURED FUSIFORM ANEURYSM IN THE INTERNAL ILIAC ARTERY WITH A CONCERTO COIL. THE ANEURYSM MAX DIAMETER WAS 2.5MM. THE COIL WAS FULLY IN THE PATIENT AND READY TO DEPLOY. THEY ATTEMPTED TO BEND THE END OF THE WIRE IN THE HYPOTUBE TO BREAK THE HYPOTUBE AND EXPOSE THE WIRE FOR COIL DETACHMENT/DEPLOYMENT. THE HYPOTUBE BROKE AND DID NOT EXPOSE THE WIRE. THE COIL WAS REPORTED TO BE IMPLANTED IN THE PATIENT. BLOOD FLOW AND VESSEL TORTUOSITY WERE REPORTED AS NORMAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PROGREAT 2.7 FR MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008707 ↗
• MalfunctionApr 14, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL COULD NOT BE ADVANCED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. IT WAS UNKNOWN WHAT CONDITION WAS BEING TREATED OR WHAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24877836 ↗
• MalfunctionApr 3, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL COULD NOT BE ADVANCED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. IT WAS UNKNOWN WHAT CONDITION WAS BEING TREATED OR WHAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED BY USING A NEW PRODUCT. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783997 ↗
• MalfunctionSep 15, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DIDN'T DETACH. THE PHYSICIAN TRIED MULTIPLE ATTEMPTS WITH THE INSTANT DETACHER. THE CONCERTO 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. ANCILLARY DEVICES INCLUDE A 2.8 PROGREAT SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755352 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT DID NOT RESULT IN PROLONGED HOSPITALIZATION. IT WAS NOTED THAT THE SUBJECT HAD BRTO (BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION) FOR GASTRIC VARICES WITH RED FOR SPLENECTOMY ON 4/26. THE SPONSOR ASSESSED AS POSSIBLY RELATED TO INDEX PROCEDURE AND NOT RELATED TO STUDY DEVICES. THE INVESTIGATOR ASSESSED AS PROBABLY RELATED TO INDEX PROCEDURE AND NOT RELATED TO STUDY DEVICE. FURTHER INFORMATION WAS RECEIVED THAT THE EVENT WAS A BASELINE CONDITION AND OCCURRED AFTER THE STUDY EXIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17238424 ↗