ConcertoTM PV-20-50-HELIX (UDI 00847536017146)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536017146), received between Feb 22, 2019 and Sep 6, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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.

• MalfunctionSep 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL PROLAPSED WITHIN THE CATHETER. FORCE WAS APPLIED AND THE COIL UNINTENTIONALLY SEPARATED FROM THE PUSHWIRE. HOWEVER, THE COIL WAS IMPLANTED WITHIN THE INTENDED LOCATION. RESISTANCE WAS FELT DURING THE ADVANCEMENT. A CONTINUOUS FLUSH WAS NOT USED. THE PUSHWIRE WAS NOT DAMAGED. THE DEVICE WAS REPOSITIONED THREE TIMES. THE DEVICE WAS ATTEMPTED TO BE DETACHED 2 TIMES WITH AN INSTANT DETACHER. MANUAL DETACHER WAS NOT ATTEMPTED. THE PUSHWIRE WAS ROTATED DURING THE DELIVERY. THE DEVICES WERE PREPARED THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8969100 ↗
• MalfunctionJul 25, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE COIL FAILED TO DETACH WITH THE INSTANT DETACHER AND AFTER THE HYPOTUBE WAS BROKEN AND THE INNER WIRE WAS PULLED. 3 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER AND 2 MANUAL DETACHMENTS WERE MADE, BUT THE COIL FAILED TO DETACH. THE ANATOMY WAS SEVERE IN TORTUOSITY. THE BLOOD FLOW WAS NORMAL. THE DEVICES WERE ALL PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8826963 ↗
• MalfunctionFeb 22, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT DURING A PROCEDURE, A CONCERTO COIL WAS UNABLE TO DETACH. THERE WERE NO REPORTS OF PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363074 ↗