ConcertoTM PV-18-40-3D (UDI 00847536033863)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536033863), received between Jan 10, 2021 and May 6, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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.

• MalfunctionMay 6, 2024Stretched; Separation Failure; Stretched; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. AT LEAST 3 ATTEMPTS WERE MADE TO SEPARATE THE COIL USING THE INSTANT DETACHER. 2 MORE ATTEMPTS WERE MADE TO SEPARATE THE COIL USING THE MANUAL METHOD. PRIOR TO THE NON-REMOVAL OF THE COIL, THERE WERE NO PROBLEM. THE PUSHER WIRE WAS OBSERVED TO BE STRETCHED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256447 ↗
• MalfunctionMar 25, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE DETACHED WITH THE INSTANT DETACHER (ID) OR THE MANUAL BREAK METHOD. THE PATIENT WAS UNDERGOING TREATMENT FOR INTERNAL BLEEDING. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE TWO DETACHMENT ATTEMPTS WERE MADE WITH THE ID, AND ONE ATTEMPT WAS MADE MANUALLY. THERE WAS SAID TO BE NO ISSUE WITH THE ID, AND ANOTHER ID WAS NOT USED. 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 11572930 ↗
• MalfunctionJan 10, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE 18X40 BECAME STUCK AND BUNCHED/DAMAGED IN THE MIDDLE OF THE MICROCATHETER. IT WAS NOTED THAT TH E CATHETER WAS DAMAGED IN THE PROXIMAL END. A SECOND COIL 20X50 WAS USED WHICH WOULD NOT DETACH MANUALLY. 3 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND ONLY ONE INSTANT DETACHER WAS USED. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED, SACCULAR SPLENIC ANEURYSM WITH A MAX DIAMETER OF 25MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11144581 ↗