Concerto Detachable Coil System PV-18-40-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536045057), received between Jan 24, 2023 and Apr 20, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Compatibility Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE DEVICE WAS NOT USED ON PATIENT. THERE WAS ACCESSORY DEVICE INCOMPATIBILITY. A 0.18" MICROCATHETER WAS USED BECAUSE A REBAR 18 CATHETER WAS NOT AVAILABLE DUE TO A BACK ORDER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE ISSUE WAS RESOLVED ON (B)(6) 2026. THE PATIENT WAS SUPPOSED TO UNDERGO THORACOABDOMINAL ANEURYSM EMBOLIZATION SURGERY OF THE POLAR LEFT RENAL ARTERY. IT HAD A DIAMETER OF 8 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. ANCILLARY DEVICES INCLUDE A VERTEBRAL CATHETER 5FR DIAGNOSTIC CATHETER AND A MOMA 150 BOSTON SCIENTIFIC CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24929582 ↗
• MalfunctionMar 5, 2026Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS PLACED IN THE VASCULATURE, BUT THE COIL REMAINED IN THE STRAIGHT SHAPE. CONCERTO DID NOT FORM THE HELICAL SHAPE. SO, COULD NOT OCCLUDE THE ARTERY. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MINIMAL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. ANCILLARY DEVICES INCLUDE A PROGREAT 021 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518060 ↗
• MalfunctionFeb 23, 2026Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE WAS COMPLETE USING ANOTHER COMPETITOR'S COIL WAS USED. ACCORDING TO THE PHYSICIAN¿S STATEMENT, THERE WERE NO CONTRIBUTING FACTORS TO THE RESISTANCE. ACCORDING TO THE PHYSICIAN¿S STATEMENT, WHEN ADVANCING THE COIL IT BECAME STUCK INSIDE THE CATHETER. IT WAS NOT SPECIFIED WHETHER IT CAME OUT SMOOTHLY FROM THE INTRODUCER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24412968 ↗
• MalfunctionOct 24, 2025Inadequacy of Device Shape and/or Size; Separation Failure; Inadequacy of Device Shape and/or Size; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS NOT POSSIBLE TO DEPLOY THE COIL, AS IT WAS NOT ASSEMBLING EASILY, AND FOR THIS REASON, THEY DECIDED TO REMOVE IT AND USE A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381395 ↗
• MalfunctionJul 23, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. FOR COILS PV-20-50-HELIX, LOT D036397, THE INTRODUCER SHEATH WAS HELD HORIZONTALLY DURING HYDRATION WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE. FOR COIL PV-18-40-HELIX, LOT D012376, IT WAS REPORTED THAT PRIOR TO THE NON-DETACHMENT EVENT, NO ISSUES WERE ENCOUNTERED, AND THE DETACHER DID NOT SHOW ANY VISUAL PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577745 ↗
• MalfunctionJan 28, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT IT WAS BELIEVED ONE OF THE THE 18MM COILS PREMATURELY DETACHED IN THE CATHETER, BUT IT IS NOT CERTAIN. THE MICROCATHETER WAS FLUSHED BEFORE EACH COIL, BUT THERE WAS NO CONTINUOUS IRRIGATION. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256901 ↗
• MalfunctionJan 28, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT IT WAS BELIEVED ONE OF THE 18MM COILS PREMATURELY DETACHED IN THE CATHETER, BUT IT IS NOT CERTAIN. THE MICROCATHETER WAS FLUSHED BEFORE EACH COIL, BUT THERE WAS NO CONTINUOUS IRRIGATION. THERE WAS NO KINK/DAMAGE TO THE CATHETER OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256898 ↗
• MalfunctionDec 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COILS BEGAN TO RELEASE IN AN ADEQUATE WAY, BUT BEFORE RELEASING IT AND ADVANCING IT THE COIL WAS DISENGAGED FROM THE INTRODUCER GUIDE WITHOUT HAVING APPLIED THE COIL RELEASE MECHANISM. DECOUPLING WAS OBSERVED BETWEEN THE COIL AND THE RELEASING FIBER. THE COIL WAS REMOVED FROM THE PATIENT AND TREATMENT WAS CONTINUED WITH ANOTHER COIL, THE DEVICE WAS DISCARDED. THE PATIENT DID NOT PRESENT ANY COMPLICATION DUE TO THE DEVICE, THE INTERVENTION COULD BE PERFORMED WITHOUT INJURIES OR DELAYS. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF PELVIC VARICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312458 ↗
• MalfunctionJan 24, 2023Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  NEW INFORMATION WAS RECEIVED. THERE WERE ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND, THE COIL DETACHED FROM THE PUSHER WIRE AUTONOMOUSLY. NO DETACHMENT ATTEMPTS WERE MADE. THE COIL SPONTANEOUSLY DETACHED ON ITS OWN AND UNRAVELED FROM THE NONSTRETCH FILAMENT. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL REMAINED IMPLANTED IN SPITE OF THE FACT IT WAS UNRAVELING INTO THE FORM OF ITS PRIMARY WIRE. THE COIL WAS ABLE TO BE PUSHED TO ITS TARGET LOCATION WITH FORCEFUL INJECTIONS OF SALINE THROUGH THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232469 ↗