IDC™ M0013614120Recalls & reported problems
Boston Scientific Corporation · Interlocking Detachable Coil · Class 2 · Implant
All models of IDC (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729158752), received between Dec 9, 2019 and Apr 14, 2023 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Stretched” (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 16, 2026.
Most reported problems
Device problems
- Stretched3
- Premature Activation2
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Remove1
- Entrapment of Device1
- Failure to Advance1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2023Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023: IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO ADVANCE. THE TARGET LESION WAS LOCATED IN MODERATELY TORTUOUS VESSEL. A 4MM X 12CM IDC 18 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL GOT STUCK WITHIN THE MICROCATHETER AND THE DEVICE WAS UNRAVEL. THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE DAME DEVICE. NO COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED IN THE COIL ARM SECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16747339 ↗MalfunctionFeb 22, 2023Stretched; Adverse Event Without Identified Device or Use Problem; Stretched; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26 JAN 2023. IT WAS REPORTED THAT THE COIL WAS DAMAGED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED INTERNAL ILIAC ARTERY. A 4MM X 12CM IDC COIL WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE DISTAL PORT OF THE DEVICE WAS STRETCHED. THE DEVICE WAS NOT PLACED INSIDE THE BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE INTERLOCKING ARM WAS FOUND DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16424352 ↗InjuryMar 23, 2021Premature Activation; Malposition of Device; Premature Activation; Malposition of Device
IT WAS REPORTED THAT THE COIL WAS NOT PLACED WITHIN THE TARGET LESION. A 4MMX12CM IDC EMBOLIC COIL WAS SELECTED FOR USE IN A CHEMO EMBOLIZATION OF THE LIVER PROCEDURE. THE 4MMX12CM IDC EMBOLIC COIL WAS ADVANCED THROUGH THE RENEGADE CATHETER AND DEPLOYED PREMATURELY NOT WITHIN THE INTENDED TARGET LOCATION OF THE LIVER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11554622 ↗MalfunctionJan 25, 2021Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation
IT WAS REPORTED THAT THE COIL PROTRUDED UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LUMBAR ARTERY. A 4MM X 12CM IDC WAS SELECTED FOR USE. DURING PROCEDURE, THE COIL PREMATURELY DETACHED INSIDE THE DISTAL PART OF THE MICROCATHETER AND WAS PROTRUDING FROM THE CATHETER'S TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11224243 ↗MalfunctionDec 9, 2019Stretched; Stretched
REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 25NOV2019. THE TARGET LESION WAS LOCATED IN THE GASTRODUODENAL ARTERY. A 4MM X 12CM IDC WAS SELECTED FOR USE. UPON WITHDRAWAL, IT WAS NOTED THAT THE COIL UNRAVELED. TO REMOVE THE UNRAVELED COIL THE PHYSICIAN HOOKED THE COIL WITH A PUSHER AND THE COIL WAS FULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. HOWEVER, DEVICE ANALYSIS REVEALED THAT INTERLOCKING ARM WAS DETACHED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9437763 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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