Concerto Detachable Coil System PV-14-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536045026), received between Mar 21, 2025 and Sep 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (1 report).

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.

• MalfunctionSep 25, 2026Incomplete or Missing Packaging; Material Deformation; Packaging Problem

  Medtronic received a report that the product was damaged upon opening the package. The assumption was that it was damaged during man ufacturing. It was noted that the patients' blood flow was normal and vessel tortuosity was moderate. All devices were prepared as indicated in the IFU and no patient complications were associated with this event. Additional information received reported the pusher wire was not secured in the black rubber stopper when the package was opened. There was no damage to the box or internal packaging. There was identified cause or contributing factor for the out-of-package damage to the Concerto coil device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898568 ↗
• MalfunctionApr 18, 2025Separation Failure; No Apparent Adverse Event; Separation Failure; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING THE COIL CONCERTO HELIX 14MM X 3 0CM, THERE WAS A NON-DETACHMENT ISSUE WITH THE COIL. TWO COILS WERE SUCCESSFULLY IMPLANTED, BUT THE THIRD COIL FAILED TO DETACH MANUALLY. THERE WERE NO INSTANT DETACHER IN USE, THEY USE MANUALLY. ATTEMPTS TO PUSH THE COIL BACK INTO THE CATHETER RESULTED IN ONE OF THE PREVIOUSLY IMPLANTED COILS BEING PULLED OUT, LEAVING ONLY ONE COIL IMPLANTED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT'S BLOOD FLOW WAS NORMAL, AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN TRIED TO IMPLANT THE THIRD COIL BUT THE THIRD DIDN¿T DETACH MANUALLY, AND WHEN THEY RETRIEVED THE COIL INTO THE CATHETER THE THIRD COILS ¿CATCH¿ AND PULL OUT THE SECOND COIL THAT IMPLANTED SUCCESSFULLY PRIOR. APPROXIMATELY 7-10 ATTEMPTS WERE MADE TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867882 ↗
• MalfunctionMar 21, 2025Migration; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN TRIED TO IMPLANT THE THIRD COIL BUT THE THIRD DIDN¿T DETACH MANUALLY, AND WHEN THEY RETRIEVED THE COIL INTO THE CATHETER THE THIRD COILS ¿CATCH¿ AND PULL OUT THE SECOND COIL THAT IMPLANTED SUCCESSFULLY PRIOR. APPROXIMATELY 7-10 ATTEMPTS WERE MADE TO DETACH THE COIL USING THE MANUAL METHOD. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. THEY EVENTUALLY IMPLANTED 8 CONCERTO COILS AND ONE MVP 7 SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667247 ↗