ConcertoTM PV-12-40-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536033832), received between Mar 9, 2021 and Mar 9, 2021 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING DEPLOYMENT OF THE CONCERTO COIL, THE COIL BECAME LODGED IN THE DISTAL END OF THE  MICROCATHETER. THE PHYSICIAN TRIED TO PULL THE COIL BACK FOR REPOSITIONING, BUT IT WOULD NOT MOVE. THEN AN ATTEMPT AT ADVANCEMENT WAS MADE, BUT THE COIL WOULD NOT MOVE. ON THE SECOND ATTEMPT TO WITHDRAW THE COIL, THE INTRODUCER WIRE CAME OUT OF THE MICROCATHETER WITH A SMALL PIECE OF THE COIL STILL ATTACHED: THE COIL HAD BROKEN. THE REST OF THE COIL WAS STILL IN THE MICROCATHETER IN THE PATIENT. THE PHYSICIAN THEN REMOVED THE MICROCATHETER AND DIAGNOSTIC CATHETER TOGETHER WHICH ALLOWED FOR THE REST OF THE COIL TO BE REMOVED WITHOUT INCIDENT. IT WAS NOTED THERE WAS NO DAMAGE TO THE MICROCATHETER, NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY UP UNTIL THE DISTAL SEGMENT, A CONTINUOUS FLUSH HAD NOT BEEN USED, REPOSITIONING WAS PERFORMED ONCE, THE PUSHWIRE WAS NOT DAMAGED, NO DETACHMENT ATTEMPTS HAD BEEN MADE, IT WAS UNKNOWN IF THE PUSHWIRE HAD BEEN ROTATED, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. IT W AS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11444613 ↗