Interlock™-35 M001363910Recalls & 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 08714729795483), received between May 4, 2021 and May 4, 2021 — classified as 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Entrapment of Device1
- Separation Failure1
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.
MalfunctionMay 4, 2021Entrapment of Device; Separation Failure; Entrapment of Device; Separation Failure
IT WAS REPORTED THAT COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH INVOLVING STENT GRAFT. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 4MM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, THE ANGIOGRAPHIC CATHETER WAS ADVANCED HOWEVER THE COIL COULD NOT BE DETACHED IN THE IL DETACHED POINT. SUBSEQUENTLY, THE COIL WAS PULLED OUT AND NOTED TO HAVE PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11773273 ↗
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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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