ConcertoTM PV-10-30-3D (UDI 00847536026483)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536026483), received between Mar 7, 2019 and Apr 20, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL SELF DETACHED IN THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT WITH A SNARE, AND NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, AND NO REPOSITION OR DETACHMENT ATTEMPTS HAD BEEN MADE. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697515 ↗
• MalfunctionMar 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT THE .021 RENEGADE CATHETER WAS IN PLACE AND ONE PV 10-30 3D COIL WAS PLACED NICELY INSIDE SACK AND DETACHED WITH NO ISSUES (MANUAL DETACHMENT). A SECOND COIL, NV 10-30 WAS DEPLOYED. THE COIL WAS RETRACTED FOR RE-POSITION. AT THIS POINT SOMETHING WAS NOTED TO BE WRONG. THE COIL COULDN'T BE REALLY PUSHED OUT, SO IT WAS WITHDRAWN (THE ENTIRE COIL AND WIRE). THE WIRE WAS TOUGH TO WITHDRAW, BUT IT KEPT COMING, THEN AN UNFAMILIAR PART WAS FELT WHEN GRABBED, AS IF SOMETHING WAS UNRAVELING. THE REP STEPPED OUT OF THE ROOM. WHEN HE RETURNED A NEW COIL WAS BEING PLACED INSIDE THE ANEURYSM. IT WAS BELIEVED THAT THE FIRST COIL DID NOT DETACH OUTSIDE THE MICRO CATHETER. WHEN THE SECOND COIL WAS PUSHED THROUGH THE MICRO CATHETER, IT MUST OF INTER TWINED WITH THE FIRST COIL. MANUAL DETACHMENT WAS THE ONLY DETACHMENT METHOD USED. ONE ATTEMPT WAS MADE. THE DEVICES WERE REPORTED NOT TO HAVE BEEN USED PER THE INSTRUCTIONS FOR USE, AS A CONTINUOUS FLUSH WAS NOT USED. NO PATIENT INJURY OCCURRED. NO IMAGES ARE AVAILABLE. THE DEVICES WERE REPORTED TO HAVE BEEN DISCARDED AT THE SITE. THE UNRUPTURED, ANEURYSM WAS IN THE LEFT INTERNAL ILIAC. THE MAX AND NECK DIAMETER WERE BOTH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8401369 ↗