IDC™ M0013615120Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729158776), received between Dec 15, 2020 and Sep 1, 2021 — classified as 1 injury, 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
Device problems
- Entrapment of Device1
- Material Integrity Problem1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2021Material Integrity Problem; Migration; Material Integrity Problem; Migration
IT WAS REPORTED THAT THE DEVICE FLOWED TO THE PERIPHERY, EMBOLIZED AND WAS REMOVED BY SNARE. THE TARGET LESION AREA WAS LOCATED IN THE SEVERELY TORTUOUS RENAL ARTERY. A 5MM X 12CM IDC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS DEPLOYED FULLY. HOWEVER, THE COIL COULD NOT BE CRIMPED WELL TO THE VESSEL AND FLOWED TO THE PERIPHERY. SUBSEQUENTLY, IT EMBOLIZED IN THE DISTAL PART OF THE LESION AND WAS REMOVED USING A GOOSENECK SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12408030 ↗MalfunctionDec 15, 2020Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS LIVER ARTERY. A 5MMX12CM IDC-18 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE MICROCATHETER. FURTHERMORE, WHEN THE COIL WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE MICROCATHETER. THE COIL WAS PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11012407 ↗
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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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