Interlock™-35 M001363810Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729793113), received between Oct 31, 2018 and Oct 24, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05OCT2023. IT WAS REPORTED THAT THE COIL WAS STUCK. THE TARGET LESION WAS IN THE LOWER LIMB. A 15MM X 25CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THE COIL AND THE CATHETER WERE REMOVED TOGETHER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE MAIN COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17998824 ↗
• MalfunctionAug 4, 2023Entrapment of Device; Stretched; Entrapment of Device; Stretched

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17459329 ↗
• MalfunctionSep 17, 2019Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22AUG2019. IT WAS REPORTED THAT THE COIL COULD NOT DETACH. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 15MMX25CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL REACHED THE LESION PART IN THE VESSEL BUT COULD NOT DETACH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM DETACHED FROM THE COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9076214 ↗
• MalfunctionJan 25, 2019Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09-JAN-2019. IT WAS REPORTED THAT COIL GOT CAUGHT IN THE HUB PART OF THE CATHETER. A 15MM/25CM .035 INTERLOCK-35 WAS SELECTED FOR EMBOLIZATION OF THE TARGET LESION. DURING THE PROCEDURE, THE COIL GOT CAUGHT IN THE HUB PART OF THE ANGIOGRAPHIC CATHETER AND COULD NOT BE INSERTED. THE COIL WAS SIMPLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT'S CONDITION IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED FROM THE COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8276941 ↗
• MalfunctionDec 5, 2018Premature Activation; Premature Activation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8133322 ↗
• MalfunctionOct 31, 2018Entrapment of Device; Material Integrity Problem; Physical Resistance/Sticking; Entrapment of Device; Material Integrity Problem; Physical Resistance/Sticking

  REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON 11-OCT-2018. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETERS TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS INTERNAL ILIAC ARTERY (IIA). A 15MM X 25CM INTERLOCK-35 COIL WAS SELECTED FOR USE FOR THE ABDOMINAL AORTIC ANEURYSM PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL CAME OUT FROM THE UNSPECIFIED ANGIOGRAPHIC CATHETER AND IT COILED UP TWO TIMES. HOWEVER, AFTER THAT, THE PHYSICIAN COULDN'T ROLL THE WHOLE COIL WELL AND THE COIL DIDN'T COME OUT FROM THE CATHETER COMPLETELY. THE COIL WAS THEREFORE SIMPLY REMOVED, BUT IN THE PROCESS IT WAS NOTICED THAT THE COIL BECAME STUCK IN THE CATHETERS TIP AND THERE WAS COIL PROTRUSION NOTED AT THE TIP OF THE CATHETER UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8025851 ↗