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Interlock™ M001361770Recalls & reported problems

Boston Scientific Corporation · Fibered IDC™ Occlusion System · Class 2 · Implant

All models of Interlock (26)

Data updated Oct 16, 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 08714729765110), received between Apr 12, 2019 and Oct 1, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Material Integrity Problem1
  • Premature Activation1
  • Use of Device Problem1

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 1, 2020Premature Activation; Material Integrity Problem; Premature Activation; Material Integrity Problem

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28SEP2020. IT WAS REPORTED THAT THE COIL DEPLOYED PREMATURELY. THE TARGET LESION AREA WAS LOCATED IN THE CORONARY ARTERY. A 2/6MM X 8 CM INTERLOCK EMBOLIC WAS SELECTED FOR USE IN A CONGENITAL CORONARY ARTERIOVENOUS FISTULA. DURING THE PROCEDURE, THE COIL WAS PUSHED INTO THE MICROCATHETER AND THE DEPLOYMENT WAS NOT SUITABLE. THE GUIDEWIRE AND COIL WAS RETRIEVED, BUT THE COIL WAS NOT FOUND. LATELY, IT WAS NOTED THAT THE COIL DEPLOYED INSIDE THE MICROCATHETER AND THE INTERLOCKING DETACHABLE ARMS WERE DAMAGED. THE COIL WAS SIMPLY PULLED OUT WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE INVESTIGATION REVEALED MISSING FIBER BUNDLES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10616963 ↗
  • MalfunctionApr 12, 2019Use of Device Problem; Use of Device Problem

    IT WAS REPORTED THAT THE DEVICE WAS USED AFTER ITS EXPIRY DATE. A 2/6MM X 8CM INTERLOCK WAS SELECTED FOR USE. THE DEVICE AND PACKAGE SEALS WERE IN GOOD CONDITION PRIOR TO USE. AN EXPIRED PRODUCT WAS IMPLANTED INTO THE PATIENT. HOWEVER, THERE WERE NO ISSUES WITH THE DEVICE. THIS WAS NOTICED POST PROCEDURE UPON FURTHER REVIEW DURING INVOICING. THE PROCEDURE AND THE CONDITION OF THE PATIENT WERE NORMAL POST PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8509230 ↗

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Sources and updates

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