Concerto Detachable Coil System PV-12-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536045002), received between May 17, 2024 and Aug 3, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114661 ↗
• MalfunctionJan 9, 2026Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE TWO COILS DID NOT DEPLOY; IT WAS IMPOSSIBLE TO DETACH THEM, AND THEY WOULD NOT ADVANCE THROUGH THE CATHETER. THERE WAS INCREASED PROCEDURE TIME AND CHANGE OF EMBOLIZATION MATERIAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS NOT RETAINED. IT WAS UNKNOWN IF THERE WAS ANY ASSESSMENT FOR PRODUCT/THERAPY/PROCEDURE RELATEDNESS MADE BY THE INVESTIGATOR, SPONSOR, OR CLINICAL EVENTS COMMITTEE.

  Patient problems: Failure of Implant

  MAUDE report 24028374 ↗
• MalfunctionJun 19, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CONCERTO COIL FAILED TO FORM A HELICAL SHAPE. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE SHAPE ISSUE WAS NOT DETERMINED. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294272 ↗
• MalfunctionMay 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL THAT HAD RESISTANCE DURING DELIVERY. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION OF A DISTAL SOFT TISSUE LIVER VESSEL. THE ARTERY DIAMETER WAS 10MM. THERE WAS NO VESSEL CALCIFICATION OR STENOSIS NOTED. THERE WERE NO ABNORMALITIES IN RELATION TO THE PATIENT'S ANATOMY ALTHOUGH PATIENT VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DEVICE WAS INSPECTED AND PREPARED PER THE INSTRUCTIONS FOR USE (IFU) WITH NO ISSUE IDENTIFIED. THE COIL COULD NOT BE PUSHED OUT AT THE TARGET EMBOLIZATION SITE; THE DEVICE WAS NOTED TO BE JAMMED.  THE DEVICE WAS NEVER IMPLANTED AND WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. PATIENT OUTCOME WAS NOTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE RESISTANCE OCCURRED IN THE DISTAL END OF THE NON-MEDTRONIC MICROCATHETER. A CONTINUOUS SALINE FLUSH ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO KINK OR OTHER DAMAGE OBSERVED TO THE COIL OR THE CATHETER AFTER REMOVAL. ANCILLARY DEVICE WAS A BOSTON SCIENTIFIC MICROCATHETER (UNSPECIFIED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972110 ↗
• MalfunctionMar 24, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT OCCURRED ON 28-FEB-2025

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679562 ↗
• MalfunctionMay 17, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE ADVANCED IN THE ATTEMPTS TO USE IT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347737 ↗