Concerto Detachable Coil System PV-5-15-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536045156), received between Mar 10, 2025 and Oct 17, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO 3D COIL COULD NOT BE ADVANCED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. 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 INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328719 ↗
• MalfunctionMar 10, 2025Break; Packaging Problem; Break; Packaging Problem

  IT WAS REPORTED THAT THE COIL CONCERTO 3D 5MM X 15CM WAS FOUND WITH A BROKEN WIRE UPON OPENING THE PACKAGE, RESULTING IN THE COIL BEING DETACHED. ADDITIONALLY, THE COIL CONCERTO HELIX 3MM X 8CM SNAPPED IN HALF WHILE BEING ADVANCED THROUGH THE HOUSING CATHETER, BUT IT WAS NOT YET IN THE DELIVERY CATHETER AND DID NOT ENTER THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INVOLVED. ANCILLARY DEVICES: GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21569263 ↗