ConcertoTM PV-10-30-3D (UDI 00847536033825)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536033825), received between Jun 1, 2022 and Apr 13, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 13, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL WAS STUCK IN THE REBAR CATHETER AND PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING AN EMBOLIZATION FOR TREATMENT OF AN UNRUPTURED, RENAL ANEURYSM WITH A MAX DIAMETER OF 28 MM AND A 9 MM NECK DIAMETER. ACCESSED VESSEL WAS 1. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS UNKNOWN AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE REBAR CATHETER (LOT # B461082) WAS KINKED. IT WAS ALSO REPORTED THE CONCERTO COIL WAS STUCK INSIDE THE MICROCATHETER. THERE WAS CATHETER RESISTANCE IN THE PROXIMAL SECTION OF THE CATHETER. IT WAS REPORTED THE CONCERTO COIL PREMATURELY DETACHED. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN THE MIDDLE SECTION OF THE CATHETER. THE CATHETER WAS NOT DAMAGED. THE COIL WAS DAMAGED ON THE PUSHWIRE IN THE DISTAL SEGMENT. IT WAS REPORTED COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE COIL WAS REMOVED FROM THE PATIENT BY PUSHING OUT FROM THE MICROCATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732779 ↗
• MalfunctionJun 1, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THE PATIENT WAS BEING TREATED FOR A GASTROINTESTINAL BLEED. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE CATHETER OR COIL. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565203 ↗