Interlock™ M001361610Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729765042), received between Nov 9, 2020 and Feb 23, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2024Difficult to Remove; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED DEVICE ANALYSIS COMPLETED ON 05FEB2024. IT WAS REPORTED THAT ADVANCING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 12MM X 20CM INTERLOCK 2D COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS ADVANCED INTO THE BODY THROUGH 18F MICROCATHETER. HOWEVER, RESISTANCE OCCURRED IN THE TORTUOUS LESION. THE PHYSICIAN RECAPTURED THE COIL AND ADVANCED AGAIN, BUT STILL COULD NOT PUSH THE DEVICE. THE COIL AND CATHETER WERE REMOVED TOGETHER, AND THE PROCEDURE WAS COMPLETED WITH A NEW COIL. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED MAIN COIL ARM DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768624 ↗
• MalfunctionDec 19, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 30NOV2023. IT WAS REPORTED THAT THE COIL FAILED TO DEPLOY AND WAS STUCK. AN 12MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL FAILED TO DEPLOY AND WAS STUCK INSIDE A NON-BSC CATHETER. INTERMITTENT FLUSHING WITH SALINE WAS USED DURING THE PROCEDURE WHILE THE COIL WAS IN THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL GOT DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355087 ↗
• MalfunctionOct 7, 2021Entrapment of Device; Premature Activation; Physical Resistance/Sticking; Entrapment of Device; Premature Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 12MM X 20CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, RESISTANCE WAS FELT UPON DEPLOYMENT. SUBSEQUENTLY, WHEN THE PHYSICIAN, TRIED TO REMOVE THE DEVICE, THE COIL GOT DETACHED FROM THE INTERLOCKING ARM OF THE PUSHER WIRE. THE DEVICE WAS THEN REMOVED THROUGH THE SHEATH AND IT WAS NOTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590738 ↗
• MalfunctionNov 9, 2020Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22OCT2020. IT WAS REPORTED THAT COIL STUCK IN THE MIDDLE OF MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 12MMX20CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, A HEPARIN SALINE DRIP WAS APPLIED UPON PLACING A RENEGADE MICROCATHETER. THE 12MMX20CM COIL WAS THEN DELIVERED BUT COULD NOT BE PUSHED AFTER ADVANCING IN THE MIDDLE OF THE CATHETER AFTER SEVERAL ATTEMPTS. SUBSEQUENTLY, THE COIL WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY. A 10CMX20CM COIL WAS THEN REPLACED AND COMPLETED THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10810156 ↗