Concerto Detachable Coil System PV-14-40-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536045323), received between Mar 11, 2025 and Dec 30, 2025 — 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.

• MalfunctionDec 30, 2025Stretched; Detachment of Device or Device Component; Unintended Movement; Stretched; Detachment of Device or Device Component; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS UNDERGOING ELECTIVE TREATMENT OF DUAL TRUE SACCULAR ANEURYSMS OF THE LEFT, DISTAL SPLENIC ARTERY. ONE ANEURYSM LOCATED AT THE BIFURCATION OF THE HILAR BRANCHES (12 × 8 MM). A SECOND, MORE DISTAL ANEURYSM LOCATED AT THE INFERIOR HILAR BRANCH (20 × 13 MM). WIDE NECK MORPHOLOGY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE TO SEVERE TORTUOSITY OF THE SPLENIC ARTERY. NO INTRA PROCEDURAL OR POST-PROCEDURAL SYMPTOMS WERE RELATED TO THE COIL EVENT. THE PATIENT REMAINED CLINICALLY ASYMPTOMATIC. DURING THE SAME PROCEDURAL SESSION, MULTIPLE ENDOVASCULAR RETRIEVAL ATTEMPTS WERE PERFORMED USING A SNARE CATHETER TO RESOLVE THE PORTION OF THE COIL REMAINING IN THE PATIENT. DUE TO PROGRESSIVE ELONGATION AND FRAYING OF THE COIL FILAMENT, RETRIEVAL WAS TECHNICALLY CHALLENGING, WITH EXTENSION OF THE FILAMENT FROM THE DISTAL SPLENIC ARTERY TO THE RIGHT EXTERNAL ILIAC ARTERY. A MORE RESISTANT PORTION OF THE FILAMENT WAS EVENTUALLY ENGAGED AND WITHDRAWN INTO THE FEMORAL INTRODUCER. A STERILE MICRO FORCEPS (1.8 MM) WAS INTRODUCED THROUGH THE FEMORAL SHEATH, ALLOWING STABLE GRASPING OF THE FILAMENT AND ADVANCEMENT OF THE GUIDING CATHET

  Patient problems: Foreign Body In Patient

  MAUDE report 23923757 ↗
• MalfunctionMar 11, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576685 ↗