IDC™ M0013613100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729158721), received between Mar 13, 2019 and Oct 1, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED REBLEEDING AND LOW HEMOGLOBIN LEVELS. THE PATIENT PRESENTED WITH A HISTORY OF PANCREATITIS, WHICH LED TO ACTIVE BLEEDING. THE PREFERRED TREATMENT FOR THIS CONDITION IS TO OCCLUDE THE PSEUDOANEURYSM USING AN INTERVENTIONAL PROCEDURE. ON (B)(6) 2024, A NON-BOSTON SCIENTIFIC (BSC) COIL WAS PLACED PERCUTANEOUSLY INSIDE THE PSEUDOANEURYSM. ON (B)(6) 2024, A COMPUTED TOMOGRAPHY (CT) SCAN DOCUMENTED THAT THE PSEUDOANEURYSM REMAINS PERMEABLE. THIS IS LIKELY DUE TO THE USE OF A SINGLE COIL, WHICH DID NOT ACHIEVE TOTAL THROMBOSIS OF THE PSEUDOANEURYSM. ON (B)(6) 2024, A 3MM X 12CM INTERLOCK, 3MM X 10CM IDC, AND 2MM X 4CM IDC WERE PLACED ENDOVASCULARLY AT THE ORIGIN OF THE LEFT GASTRIC ARTERY, WHICH PROVIDED IRRIGATION TO THE LEFT GASTRIC ARTERY. ON (B)(6) 2024, A CT SCAN WAS PERFORMED DUE TO REBLEEDING AND LOW HEMOGLOBIN LEVELS, FINDING A PERMEABLE PSEUDOANEURYSM AFTER OCCLUSION OF THE NOURISHING ARTERY WITH THE BSC THREE COILS. ON (B)(6) 2024, BASED ON THE TOMOGRAPHY FINDINGS, THE PHYSICIAN DECIDED TO PLACE ADDITIONAL NON-BOSTON SCIENTIFIC COILS. A REPEAT CONTROL AT 15 MINUTES SHOWED NO VISUALIZED FLOW DISTAL TO THE COILS INSIDE THE LEFT GASTRIC

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 20346310 ↗
• InjuryAug 8, 2022Premature Activation; Premature Activation

  IT WAS REPORTED A SNARE WAS USED TO RECOVER THE COIL AND THE PROCEDURE WAS CANCELLED. THE 9.8MMX2MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS ANTERIOR SUPERIOR PANCREATICODUODENAL ARTERY. A 3MMX10CM IDC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE COIL WAS CAUGHT IN THE COIL THAT WAS EMBOLIZED EARLIER AND EARLY DETACHED IN THE DISTAL PART OF THE CATHETER WHEN IT WAS FORCIBLY PULLED BACK. A SNARE WAS USED FOR REMOVAL AND DEVICE WAS RECOVERED. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188317 ↗
• MalfunctionJun 1, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07MAY2021. IT WAS REPORTED THAT COIL WAS STUCK INSIDE THE CATHETER. A 3MM X 10CM IDC-18 WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK INSIDE THE RENEGADE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917899 ↗
• InjuryMar 13, 2019Material Protrusion/Extrusion; Migration; Material Protrusion/Extrusion; Migration

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE VESSEL AND MIGRATED TO ANOTHER VESSEL. A 3MM X 10CM IDC 18 SOFT COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BACKED OUT FROM THE ARTERY AFTER IT WAS DEPLOYED FULLY IN THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO SNARE THE COIL; HOWEVER, IT RECOILED BACK OUT INTO ANOTHER VESSEL AND WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND A SMALLER SIZED COIL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417641 ↗