IDC™ M0013612040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729158691), received between Dec 19, 2018 and Nov 7, 2024 — classified as 2 injuries, 2 malfunctions.

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

• MalfunctionNov 7, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE COIL GOT SEPARATED. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL. A 2MM X 4CM IDC EMBOLICS WAS SELECTED FOR USE. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO RETRACT THE COIL INTO THE OUTER SHEATH, BUT IT COULD NOT BE WITHDRAWN, LEADING TO THE COIL BECOMING DETACHED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE COIL DETACHED FROM THE LOCKING ARM WHEN RETRACTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630955 ↗
• 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 20347330 ↗
• MalfunctionNov 7, 2022Detachment of Device or Device Component

  EARLY 80¿S FEMALE WITH NEW ONSET OF RECTAL BLEEDING. PROCEDURE: INTERNAL MAMMARY ARTERY (IMA) ANGIOGRAM, LEFT COLIC ARTERY BRANCH IMA AND SUPERIOR ANGIOPLASTY RECTAL ARTERY ANGIOPLASTY. THERE WAS A DEPLOYMENT MALFUNCTION THEN THE MICROCATHETER BROKE NEAR THE HUB. NO KNOWN HARM TO PATIENT. ANOTHER DEVICE USED FOR PROCEDURE WITHOUT PROBLEMS. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, IDC¿ (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743049 ↗
• InjuryDec 19, 2018Premature Activation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED THE COIL WAS PLACED OUTSIDE OF THE TARGET VESSEL. A 7MM X 20CM IDC WAS SELECTED FOR AN ARTERIAL ANEURYSM EMBOLIZATION. INTERMITTENT FLUSH WAS USED. THE LENGTH WAS NOTED TO BE LONG FOR THE LESION WHEN TRYING TO PLACE. AS THE COIL WAS RETRACTED, IT BECAME DETACHED WITHIN THE NON-BSC CATHETER. IT WAS NOT NOTICED THE COIL HAD DETACHED AND ANOTHER COIL WAS INSERTED. SINCE THE FIRST COIL REMAINED IN THE CATHETER, IT WAS PUSHED BY THE NEW COIL AND THE COMPLAINT COIL INSIDE THE CATHETER ENTERED THE BODY FROM THE TIP OF THE CATHETER. WHEN THE CATHETER WAS MOVED, IT SEEMED THAT THE COIL WAS PLACED INTO THE BODY. HOWEVER, IT WAS NOT IN THE ANEURYSM. THE PHYSICIAN TRIED TO RETRIEVE THE COIL, BUT THE SNARE COULD NOT BE USED WITH THE 4FR SYSTEM. THE HUB OF THE MICROCATHETER WAS CUT AND IT WAS CHANGED TO 6FR SYSTEM. AFTER THAT, THE COIL WAS RETRIEVED BY SNARE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179164 ↗