Interlock™ M001361750Recalls & 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 08714729765097), received between Oct 6, 2021 and Oct 6, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (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
- Premature Activation1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2021Premature Activation; Stretched; Premature Activation; Stretched
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16SEP2021. IT WAS REPORTED THAT THE COIL PREMATURELY DETACHED IN THE CATHETER. A VORTX DIAMOND 2/4MM X 4.1CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL PREMATURELY DETACHED IN THE CATHETER. PER PHYSICIAN'S COMMENT, THERE WAS UNRAVELLING CAUSED BY THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12585019 ↗
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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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