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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536045118), received between Nov 1, 2024 and Apr 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Inadequacy of Device Shape and/or Size; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT CONCERTO COILS WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY OF A RENAL BLEED. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT UPON ACCESS OF THE RENAL VESSEL THE PHYSICIAN ATTEMPTED TO DEPLOY THE CONCERTO COIL AND WAS UNSUCCESSFUL X 3. THE STAFF REPORTED THAT THE COIL WOULD SUCCESSFULLY EXIT THE CATHETER BUT WOULD NOT TAKE SHAPE. THREE SIZES WERE ATTEMPTED AND FAILED. THREE SIZES WERE SUCCESSFULLY DEPLOYED. ALL DEVICES WE PREPARED AS INDICATED IN THE IFU. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A AVANTI 6F SHEATH, OMNI SOS GUIDE CATHETER, RENEGADE HIGH FLOW MICRO CATHETER, FATHOM GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25047103 ↗
• MalfunctionDec 6, 2024

  DOCTOR TRIED DEPLOYING COIL, BUT COIL WAS NOT DEPLOYING INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863125 ↗
• MalfunctionNov 1, 2024Break; Separation Failure; Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE DETACHED/DEPLOYED. IT WAS NOTED THAT THERE WAS COIL SEPARATION/BREAK /PREMATURE DETACHMENT. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN HAD NOT REPOSITIONED THE COIL. THREE DETACHMENT ATTEMPTS HAD BEEN MADE WITH THE INSTANT DETACHERS. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANEURYSM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587531 ↗