Interlock™ M001361540Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729764977), received between Oct 31, 2019 and Dec 16, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2021Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07DEC2021. IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED. A F-IDC 2D 5MM X 8CM INTERLOCK COIL WAS SELECTED FOR USE IN AN ARTERY EMBOLIZATION PROCEDURE. DURING DEPLOYMENT, THE COIL PREMATURELY DEPLOYED IN THE CATHETER. IT COULD NOT BE DEPLOYED TO THE TARGET LOCATION. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022205 ↗
• MalfunctionFeb 7, 2020Entrapment of Device; Stretched; Entrapment of Device; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17JAN2020. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN A HEPATIC ARTERY. A 5MM X 8CM INTERLOCK COIL WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE MIDDLE PART OF THE CATHETER AND IT COULD NOT BE PUSHED OR WITHDRAWN. FURTHERMORE, THE COIL BECAME STRETCHED. THE COIL WAS REMOVED WITHIN THE CATHETER ALL TOGETHER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9681716 ↗
• MalfunctionOct 31, 2019Difficult to Insert; Material Integrity Problem; Difficult to Insert; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09OCT2019. IT WAS REPORTED THAT THERE WAS RESISTANCE IN ADVANCING THE COIL. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 5MMX8CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, HIGH RESISTANCE WAS FELT UPON ADVANCING THE COIL INTO THE LESION AND FAILED TO DEPLOY. THE COIL WAS THEN REMOVED TOGETHER WITH THE CATHETER FROM THE PATIENT'S BODY, HOWEVER, IT WAS DAMAGED UPON WITHDRAWAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9262481 ↗