Interlock™-35 M001363700Recalls & reported problems
Boston Scientific Corporation · Fibered IDC™ Occlusion System · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729792994), received between May 2, 2019 and May 2, 2019 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Physical Resistance/Sticking1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
IT WAS REPORTED THAT THE COIL BROKE DURING USE. A 4MM X 6CM INTERLOCK .035 COIL WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. THE COIL WAS ADVANCED INTO THE MICROCATHETER AND AFTER 1CM ADVANCEMENT BECAME VERY DIFFICULT. AN ATTEMPT TO PULL THE COIL BACK WAS MADE BUT DID NOT WORK. THE COIL WAS NOTED TO BE CRACKED IN THE CATHETER. THE COIL AND CATHETER WERE REMOVED FROM THE PATIENT TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8575115 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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