Interlock™ M001361630Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729765066), received between Dec 13, 2018 and Nov 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (2 reports).

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.

• MalfunctionNov 22, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30OCT2024. IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED INSIDE THE CATHETER. A 14MM X 20CM INTERLOCK WAS SELECTED FOR USE IN A SPLENIC ARTERY EMBOLIZATION. DURING THE PROCEDURE, THE INTERLOCKING ARM DISENGAGED PREMATURELY INSIDE THE STC-18 MICROCATHETER AND COULD NOT BE PUSHED FORWARD. THE WHOLE DELIVERY SYSTEM WAS WITHDRAWN TOGETHER WITH THE COIL, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED FROM THE ARM OF THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758967 ↗
• MalfunctionNov 11, 2020Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23OCT2020. IT WAS REPORTED THAT THE COIL STUCK IN THE CATHETER. A 14MMX20CM INTERLOCK WAS SELECTED FOR USE IN A BRONCHIAL ARTERY EMBOLIZATION PROCEDURE. DURING PROCEDURE, THE COIL WAS DEPLOYED BUT IT GOT STUCK. THE MICROCATHETER WAS THEN RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED DETACHED INTERLOCKING ARM AND MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10825137 ↗
• MalfunctionDec 13, 2018Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22-NOV-2018. IT WAS REPORTED THAT THE COIL UNLOCKED INSIDE THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 14MMX20CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE PHYSICIAN RETRIEVED THE COIL FOR REPOSITIONING, IT WAS NOTED THAT THE COIL UNLOCKED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED WITH THE CATHETER. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS POST-PROCEDURE WAS STABLE. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS NOT RETURNED SINCE IT IS DETACHED FROM THE PUSHER WIRE. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. A PUSHER WIRE AND AN INTRODUCER SHEATH WERE RETURNED FOR THIS COMPLAINT. THE COIL WAS NOT RETURNED. THE TWIST LOCK OF THE INTRODUCER SHEATH HAD BEEN OPENED. THE INTRODUCER SHEATH WAS INSPECTED AND NO ANOMALIES WERE NOTED. THE PUSHER WIRE WAS INSPECTED AND WAS FOUND BROKEN AND STRETCHED NEAR THE DISTAL END. MICROSCOPIC INSPECTION OF THE PUSHER WIRE REVEALED THAT THE PROXIMAL END HAS A SMOOTH SURFACE. THE INTERLOCKING ARM WAS NOT RETURNED SINCE IT IS DETACHED FROM T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160235 ↗