Interlock™-35 M001363660Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729797432), received between Sep 28, 2018 and Jun 30, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026

  BOSTON SCIENTIFC COIL DID NOT DEPLOY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665449 ↗
• MalfunctionDec 10, 2024Separation Failure; Adverse Event Without Identified Device or Use Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25NOV2024. IT WAS REPORTED THAT THE COIL FAILED TO DEPLOY. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 18MM X 20CM INTERLOCK-35 COIL WAS ADVANCED FOR EMBOLIZATION. DURING THE DEPLOYMENT, THE INTERLOCKING ARM COULD NOT BE OPENED. THE PROCEDURE WAS COMPLETED WITH THE SAME TYPE OF DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894664 ↗
• MalfunctionJul 25, 2022Entrapment of Device; Difficult to Remove; Failure to Advance; Entrapment of Device; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED PORTAL VEIN. AN 18MMX20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER. THE COIL WAS THEN REMOVED FROM THE PATIENT'S BODY TOGETHER WITH THE CATHETER. HOWEVER, IT WAS NOTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15097898 ↗
• MalfunctionJul 13, 2022Entrapment of Device; Difficult to Remove; Failure to Advance; Entrapment of Device; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS INTERNAL ILIAC ARTERY. AN 18MM X 20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS HYDRATED INTERMITTENTLY HOWEVER THE COIL GOT STUCK INSIDE THE DISTAL PART OF THE CATHETER. SUBSEQUENTLY, THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AND NOTED PROTRUDING AT THE CATHETER TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008697 ↗
• MalfunctionSep 28, 2018Material Protrusion/Extrusion; Mechanical Jam; Material Protrusion/Extrusion; Mechanical Jam

  IT WAS REPORTED THAT A COIL PROTRUDED AT THE TIP OF THE CATHETER. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS ANEURYSM. A 2DX20CM .035 INTERLOCK WAS SELECTED FOR EMBOLIZATION OF THORACOABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, A STENT GRAFT WAS PLACED FROM THE FEMORAL JUST ABOVE THE SUPERIOR MESENTERIC ARTERY. THE DEVICE WAS THEN PLACED IN THE DISTAL END OF THE STENT GRAFT TO PREVENT ENDO LEAK AFTER PLACING THE 20-40CUBE AND 18-40 2D SEQUENTIALLY FOR A TOTAL OF 8 COILS; HOWEVER, IT WAS NOTED THAT THE COIL BECAME STUCK INSIDE THE IMAGER 2 CATHETER AND COULD NOT BE PUSHED FORWARD. SUBSEQUENTLY, THE COIL PROTRUDED OUT FROM THE TIP OF THE CATHETER AND WAS EXPOSED IN THE BLOOD VESSEL BUT WAS ABLE TO BE PULLED BACK INTO THE CATHETER. THE DEVICE WAS THEN CAREFULLY PULLED OUT FROM THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS NOTED AND THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7919479 ↗