Interlock™-35 M001363720Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729793069), received between Feb 28, 2020 and Apr 1, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent1
- Physical Resistance/Sticking1
- Premature Activation1
- Separation Failure1
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.
MalfunctionApr 1, 2022Premature Activation; Separation Failure; Premature Activation; Separation Failure
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COIL FAILED TO DETACH. DURING THE PROCEDURE, A 6MM X 10CM INTERLOCK WAS SELECTED FOR USE. THE COIL WAS DEPLOYED THROUGH THE 5F SINGLE CURVED IMAGING CATHETER; HOWEVER, THE DEVICE FAILED TO DETACH AFTER PUSHING SEVERAL TIMES. THE COIL WAS WITHDRAWN FROM THE PATIENT AND THE PHYSICIAN FOUND THE COIL GOT DETACHED WITHOUT OPERATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13978778 ↗MalfunctionFeb 28, 2020Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12FEB2020. IT WAS REPORTED THAT THE COIL PUSHER WAS BENT. A 6MM X 10CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE COIL WAS INTRODUCED INTO AN ANGIODYNAMIC BERN CATHETER, THE PHYSICIAN PUSHED THE COIL PAST THE END OF THE CATHETER AND THE COIL PUSHER MADE A 90 DEGREE BEND. THE PHYSICIAN WAS UNABLE TO RETRACT THE COIL PUSHER AND HAD TO PULL EVERYTHING OUT AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT CONDITION WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS NOT RETURNED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9771289 ↗
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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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