Interlock™-35 M001363930Recalls & 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 08714729796114), received between Jul 18, 2019 and Jun 14, 2021 — classified as 2 malfunctions.
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
- 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.
MalfunctionJun 14, 2021Separation Failure; Separation Failure
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02JUN2021. AN INTERLOCK-35 EMBOLIC COIL WAS SELECTED FOR USE IN A COILING PROCEDURE, TO TREAT AN ANEURYSM. DURING THE PROCEDURE, THE PUSHER WIRE ARMS COULD NOT BE DETACHED IN THE VESSEL. CONTINUOUS FLUSHING AND MANIPULATION WAS PERFORMED TO DETACH THE WIRE, BUT IT DID NOT WORK. THE COIL WAS REMOVED VIA THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERLOCK-35 EMBOLIC COIL. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE INTERLOCKING ARM WAS DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11996943 ↗MalfunctionJul 18, 2019Entrapment of Device; Entrapment of Device
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25JUN2019. IT WAS REPORTED THAT RESISTANCE WAS FELT AND THE COIL BECAME STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. AN 8MM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, EMBOLIZATION WAS PERFORMED ON EACH OF THE UPPER AND LOWER INGUINAL ARTERY. THE PROCEDURE WAS PERFORMED UNDER CONTINUOUS REFLUX BUT SEVERE RESISTANCE WAS FELT IMMEDIATELY AFTER COIL DELIVERY. SUBSEQUENTLY, THE COIL GOT STUCK IN THE CATHETER AND WAS REMOVED TOGETHER WITH THE DELIVERY WIRE. A DIFFERENT COIL WAS THEN USED BUT THE SAME ISSUE OCCURRED AND WAS NOT RESOLVED. HOWEVER, DEVICE ANALYSIS REVEALED MISSING COIL FIBER BUNDLES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8803455 ↗
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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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