Interlock™ M001361560Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729764991), received between Apr 1, 2020 and Aug 23, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 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.

• MalfunctionAug 23, 2023Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE. A 6MM X 10CM F-IDC 2D COIL WAS SELECTED FOR PULMONARY COLLATERAL EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS ADVANCED INSIDE THE BOSTON SCIENTIFIC MICROCATHETER, BUT IT WAS NOTED THAT THE TARGET LESION WAS NOT IDEAL. THEREFORE, THE DEVICE WAS ADJUSTED. HOWEVER, IT GOT STUCK INSIDE THE MICROCATHETER AND COULD NOT BE PUSHED OUT. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AS IT COULD NOT BE DELIVERED AFTER MULTIPLE ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH A NEW MICROCATHETER AND ANOTHER OF THE SAME COIL. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED COIL AT THE ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17607289 ↗
• MalfunctionNov 12, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 6MM X 10CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE BECAME STUCK IN THE DISTAL PART OF THE CATHETER. FLUSHING WAS PERFORMED INTERMITTENTLY PRIOR TO REMOVING THE COIL. HOWEVER, IT WAS FURTHER NOTED THE COIL PROTRUDED FROM THE CATHETER'S TIP UPON REMOVAL ON BOTH CATHETER AND THE COIL TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805098 ↗
• InjuryJun 3, 2021Premature Activation; Material Integrity Problem; Physical Resistance/Sticking; Premature Activation; Material Integrity Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COIL PREMATURELY DETACHED INSIDE THE PATIENT'S BODY AND WAS SNARED TO REMOVE. A 6MMX10CM INTERLOCK COIL WAS SELECTED FOR USE ON THE UTERINE ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL PREMATURELY DETACHED INSIDE THE PATIENT'S BODY AND A SNARE WAS USED TO REMOVE THE COIL. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THE PHYSICIAN USED RENEGADE STC18 MICROCATHETER TO DELIVER THE COIL. AT THE BEGINNING, THE POSITION OF THE COIL WAS NOT SUITABLE, AND IT WAS WITHDRAWN AND DEPLOYED AGAIN. BECAUSE THE COIL COULD NOT BE PUSHED, IT COULD ONLY BE WITHDRAWN. THE COIL WAS DETACHED DURING DEVICE REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930900 ↗
• MalfunctionMay 7, 2020Entrapment of Device; Material Protrusion/Extrusion; Entrapment of Device; Material Protrusion/Extrusion

  IT WAS REPORTED THAT DEVICE PROTRUDED FROM THE CATHETER TIP. THE TARGET LESION WAS IN A MODERATELY TORTUOUS VESSEL. A 6MMX10CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF A NON-BSC CATHETER AND PROTRUDED FROM THE CATHETER'S TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10032938 ↗
• MalfunctionApr 1, 2020Entrapment of Device; Material Protrusion/Extrusion; Entrapment of Device; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A COIL PROTRUSION OCCURRED DURING REMOVAL. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS BLOOD VESSEL. A 6MM X 10CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE GOT STUCK INSIDE THE MICROCATHETER. SUBSEQUENTLY, ONLY THE COIL WAS REMOVED AND 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 PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9910273 ↗