Concerto Detachable Coil System PV-2-6-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536045095), received between Nov 20, 2025 and Mar 6, 2026 — 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.

• MalfunctionMar 6, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A HEMORRHOIDS. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE TREATMENT OF CHOICE WAS EMBOLIZATION OF SUPERIOR RECTAL ARTERY BRANCHES USING A NON-MEDTRONIC MICROCATHETER WITH COILS. ALL DEVICES INVOLVED WERE PREPARED AS PER INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS UNDER CONTINUOUS FLUSHING THROUGH THE ENTIRE OPERATION. THE PV-2-6-3D CONCERTO COIL WAS PREPARED AS PER IFU. THE PHYSICIAN ADVANCED THE COIL THROUGH THE MICROCATHETER, AND AT ABOUT HALF OF THE MICROCATHETER'S LENGTH THE COIL GOT STUCK AND COULD NOT MOVE FORWARD. THE PHYSICIAN DECIDED NOT TO USE EXCESSIVE FORCE AND TO RETRIEVE BACK THE COIL. THE COIL WAS TAKEN OUT OF THE PATIENT. THE OPERATION WENT ON USING THE BALD SPI018 COILS ON THE SAME MICROCATHETER WITH NO ISSUE AT ALL. THE COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THERE WAS NO DAMAGE TO THE CATHETER AND COIL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537283 ↗
• MalfunctionNov 20, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED GASTROINTESTINAL ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 1 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT CONCERTO COIL 2 MM X 6MM WAS UNABLE TO DEPLOY AND BECAME STUCK IN MIDDLE SECTION OF THE HEADWAY 17 MICRO CATHETER. THE COIL WAS REMOVED AND DIFFERENT COIL WAS USED. THE CATHETER AND THE COIL WERE NOT DAMAGED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606647 ↗