IDC™ M0013614080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729158745), received between Dec 13, 2018 and Feb 12, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• InjuryFeb 12, 2026Break; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL UNRAVELED AND PROTRUDED FROM THE TARGET LOCATION, REQUIRING ADDITIONAL INTERVENTION. AN IDC 18 SOFT COIL 4MM X 8CM WAS SELECTED FOR A VARICOELE EMBOLIZATION PROCEDURE. THE IDC 18 SOFT COIL 4MM X 8CM WAS IMPLANTED IN ADDITION TO MULTIPLE OTHER EMBOLIC COILS. WHEN DEPLOYING THIS COIL, HOWEVER, THERE WERE SLIGHT ISSUES DURING DEPLOYMENT, AND THE COIL WAS RE-SHEATHED AS IT DIDN'T DEPLOY CORRECTLY. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE. OVERNIGHT, THE PATIENT EXPERIENCED PAIN AND DISCOMFORT AND NOTICED A COIL PROTRUDING OUT OF AN OPEN-WOUND SCALPEL INCISION IN THEIR GROIN. A COMPLEX EXTRACTION WAS PLANNED FOR THE NEXT DAY. AT THE TIME OF PRESENTATION, IT SEEMED THE COIL WAS SANDWICHED BETWEEN SEVERAL OTHER COILS USED DURING VARICOCOELE EMBOLISATION. THEREFORE, SIMPLY PULLING IT WAS NOT FEASIBLE AS THIS RISKED DISLODGING PROXIMAL COILS. INSTEAD, IT WAS APPROACHED FROM THE NECK AND GROIN AT THE SAME TIME, AND THEY WERE ABLE TO SNAP THE COIL IN THE RENAL VEIN. DURING THE EXTRACTION, THE COIL WAS HALF-REMOVED, WITH A SMALL AMOUNT LEFT WITHIN THE RENAL VEIN. NO COIL WAS LEFT IN THE INFERIOR VENA CAVA (IVC) OR RIGHT COMMON ILIAC VEIN (RCIV).

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 24323196 ↗
• MalfunctionMar 15, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE MAIN COIL WAS BROKEN. THE STENOSED TARGET LESION WAS LOCATED IN LEFT UPPER ARM. A 4MMX8CM IDC WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THERE WAS RESISTANCE MET WHICH THE ARM SEEMED TO BE CAUGHT AND LIKE A COIL WITH A SMALL DIAMETER REMAINED IN THE SHEATH. OUTSIDE PATIENT'S BODY, IT WAS NOTED THAT THE MAIN COIL WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT DURING REMOVAL OF THE SHEATH, IT WAS NOTED THAT THE TIP SECTION OF THE COIL NEAR THE INTERLOCKING ARM WAS BROKEN AND WAS UNDER THE GAUZE. THE PHYSICIAN BELIEVED THAT THE COIL WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485944 ↗
• MalfunctionDec 13, 2018Stretched; Migration; Stretched; Migration

  IT WAS REPORTED THE COIL CAME OUT OF THE TARGET VESSEL. A 4MM X 8CM IDC WAS SELECTED FOR USE IN A SEVERELY TORTUOUS VESSEL. AFTER THE COIL WAS PLACED INTO THE LESION, THE DETACHED PUSHER WIRE BECAME CAUGHT IN THE PLACED COIL. THE COIL BECAME UNRAVELED WHILE PUSHING/PULLING IT SEVERAL TIMES. THE COIL WAS NOT PLACED PROPERLY AND CAME OUT OF THE TARGET VESSEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8162619 ↗