Interlock™-35 M001363500Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729793151), received between Aug 5, 2019 and Jun 26, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED POST SEDATION. A 3MM X 4CM INTERLOCK-35 COIL WAS SELECTED FOR USE. THE PATIENT WAS PUT UNDER ANESTHESIA. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF THE CATHETER. ONLY THE COIL WAS PULLED OUT, AND THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14824123 ↗
• MalfunctionMar 12, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 3MM X 4CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE MIDDLE OF THE CATHETER. THE ENTIRE CATHETER WAS REMOVED AND THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13744546 ↗
• MalfunctionDec 6, 2021Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17NOV2021. IT WAS REPORTED THAT THE DEVICE COULD NOT BE DETACHED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL. A 3MM X 4CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT BE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12945181 ↗
• MalfunctionMay 21, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INFERIOR MESENTERIC ARTERY. A 3MMX4CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE 5F NON BSC CATHETER. FURTHERMORE, WHEN THE COIL WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10079752 ↗
• MalfunctionMar 30, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INFERIOR MESENTERIC ARTERY. A 3MMX4CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE MICROCATHETER. FURTHERMORE, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897976 ↗
• MalfunctionMar 30, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INFERIOR MESENTERIC ARTERY. A 3MMX4CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE MICROCATHETER. FURTHERMORE, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897898 ↗
• MalfunctionDec 12, 2019Entrapment of Device; Material Protrusion/Extrusion; Entrapment of Device; Material Protrusion/Extrusion

  IT WAS REPORTED THAT COIL PROTRUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE INFERIOR MESENTERIC ARTERY. A 3MMX4CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, THE COIL BECAME STUCK IN THE DISTAL PART OF A NON-BSC MICROCATHETER AND WAS THEN REMOVED AS USUAL. HOWEVER, THE COIL WAS NOTED PROTRUDING FROM THE CATHETER'S TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9459919 ↗
• MalfunctionSep 25, 2019Stretched; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2019. IT WAS REPORTED THAT THE MAIN COIL WAS STRETCHED. THE TARGET AREA WAS LOCATED IN A MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. DURING PROCEDURE, AFTER AN IMAGER BERN CATHETER WAS INSERTED VIA CROSS OVER APPROACH, A 6MM X 20CM AND A 4MM X 6CM INTERLOCK COIL WERE DEPLOYED. A 3MM X 4CM .035 INTERLOCK COIL WAS USED FOR EMBOLIZATION. SUBSEQUENTLY, THE 3MM X 4CM .035 INTERLOCK WAS INSERTED; HOWEVER, THE COIL BECAME UNRAVELED/STRETCHED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND IMAGING WAS PERFORMED. THE BLOOD FLOW WAS BLOCKED, THUS, THE PROCEDURE WAS ENDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119134 ↗
• InjuryAug 5, 2019Premature Activation; Malposition of Device; Premature Activation; Malposition of Device

  IT WAS REPORTED THAT THE COIL DEPLOYED PREMATURELY IN THE PATIENT'S BODY PRIOR TO REACHING THE TARGET LESION. A 3MMX4CM INTERLOCK-35 WAS SELECTED FOR USE FOR A VENOUS THROMBOEMBOLISM PROCEDURE. DURING THE PROCEDURE, THE COIL PREMATURELY DEPLOYED IN THE PATIENT'S BODY BEFORE REACHING THE TARGET LESION AND WAS THEN REMOVED BY SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8859496 ↗