Interlock™ M001361480Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729845263), received between Jul 5, 2019 and Jun 24, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjuryJun 24, 2022Break; Difficult to Remove; Separation Failure; Packaging Problem; Break; Difficult to Remove; Separation Failure; Packaging Problem

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. A 2MM X 4CM INTERLOCK WAS SELECTED FOR USE IN A RENAL EMBOLIZATION TO TREAT A PSEUDOANEURYSM. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A NON BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14806350 ↗
• MalfunctionSep 2, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. A 2MM X 4CM INTERLOCK WAS SELECTED FOR USE IN A VASCULAR EMBOLIZATION PROCEDURE TO TREAT DUODENAL BLEEDING. THE ANATOMY WAS SEVERELY TORTUOUS. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER AND PROTRUDED FROM THE CATHETER TIP. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413878 ↗
• InjuryFeb 18, 2020Break; Entrapment of Device; Premature Activation; Detachment of Device or Device Component; Break; Entrapment of Device; Premature Activation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE COIL SEPARATED FROM THE MIDDLE PART AND REMAINED INSIDE PATIENT. THE TARGET LESION WAS LOCATED IN THE BRONCHIAL ARTERY. A 2MMX4CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT AS NOTED THAT THE COIL BECAME STUCK ON THE TIP PART OF A NON-BSC CATHETER AND WAS REMOVED. HOWEVER, THE COIL SEPARATED AT THE MIDDLE PART AND WAS LEFT INSIDE PATIENT FROM BRONCHIAL ARTERY TO AORTA. THE PROXIMAL SIDE WAS REMOVED PROTRUDING FROM THE CATHETER'S TIP. THERE WAS NO RESISTANCE UPON RETRIEVING THE CATHETER AND THE COIL AND NO POSSIBILITY OF ADHESION OF THROMBUS. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. IT WAS FURTHER REPORTED THAT THE FIRST COIL THAT BROKE AND DETACHED WITHIN THE PATIENT WAS A 8CMX3MM INTERLOCK AND THE SECOND COIL WAS THE 2MMX4CM INTERLOCK WHICH PREMATURELY DEPLOYED WITHIN THE CATHETER AND POSSIBLY TORE WITHIN THE CATHETER DURING REMOVAL.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 9721896 ↗
• MalfunctionJul 5, 2019Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14-JUN-2019. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED AND DEPLOYED PREMATURELY IN THE MICROCATHETER. THE TARGET AREA WAS LOCATED IN A MODERATELY TORTUOUS AND MILDLY CALCIFIED INTERNAL ILIAC ARTERY. A 2MM X 4CM INTERLOCK WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. DURING PROCEDURE, THE COIL COULD NOT BE DELIVERED TO THE TARGET AREA AND SUBSEQUENTLY, PREMATURELY DEPLOYED INSIDE THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE COIL WITHIN THE CATHETER AND BOTH DEVICES WERE REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS NOTED THAT THE MAIL COIL WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764557 ↗