ConcertoTM PV-4-10-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536026353), received between Feb 6, 2019 and Feb 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Failure” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT, THE CONCERT COIL WOULD NOT DETACH USING MANUAL DETACHMENT METHOD (BREAKING HYPOTUBE METHOD; AN ALTERNATIVE METHOD PRESENTED IN THE INSTRUCTION FOR USE). IT WAS REPORTED THAT PHYSICIAN DID NOT USED INSTANT DETACHER TO DETACH THE COIL BUT DIRECTLY TRIED TO DETACH WITH HYPOTUBE BREAK AND COIL DID NOT DETACH. UPON RETRIEVAL OF THE COIL IT DETACHED WITHIN THE MICROCATHETER. A SECOND CONCERTO COIL WAS THEN NAVIGATED THROUGH THE MICROCATHETER AND USED TO DELIVER THE REMAINING PROXIMAL COIL INTO THE INTENDED LOCATION. NO PATIENT INJURY WAS REPORTED. THE ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8310245 ↗