ConcertoTM PV-6-20-3D (UDI 00847536026407)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536026407), received between Oct 1, 2018 and Feb 24, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL WAS BEING ADVANCE IN THE HUB OF THE RENEGADE HI-FLO MICROCATHETER, RESISTANCE WAS FELT AND THEN THE CONCERTO COIL PREMATURELY DETACHED INSIDE THE PROXIMAL SECTION OF THE MICROCATHETER. THE IMPLANT COIL DID PUSH SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). HOWEVER, THE CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE PUSHWIRE WAS NOT ROTATED AND THE COIL WAS NOT ATTEMPTED TO BE DETACHED. THERE WAS NO DAMAGE NOTICED TO THE CATHETER OR COIL PRIOR TO THIS EVENT. THE VESSEL ANATOMY AND THE BLOOD FLOW WERE BOTH NORMAL. THE PATIENT WAS UNDERGOING TREATMENT FOR A GASTROINTESTINAL BLEED (GI). NO IMAGES ARE AVAILABLE. THE DEVICES WILL BE RETURNED FOR ANALYSIS. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9747632 ↗
• MalfunctionDec 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THE CONCERTO COIL PREMATURELY DETACHED. NO PATIENT INJURY OCCURRED. THE CUSTOMER WAS NOTIFIED TO RETURN THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174230 ↗
• MalfunctionOct 1, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING A COILING PROCEDURE, THE CONCERTO COIL WAS FULLY DEPLOYED BUT WOULD NOT DETACH. A NEW DETACHER WAS USED AS WELL AS THE BACKUP METHOD. MULTIPLE ATTEMPTS WERE MADE VIA THE INSTANT DETACHER AND THE MANUAL METHOD TO DETACH THE COIL, BUT ALL FAILED. THE COIL WAS REPOSITIONED SEVERAL TIMES TOO. A CONTINUOUS FLUSH WAS NOT USED. THE ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7922026 ↗