Interlock™ M001361490Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729845270), received between Dec 9, 2019 and Dec 20, 2022 — classified as 1 injury, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02DEC2022. IT WAS REPORTED THAT ADVANCING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A 2MM X 6CM AND 3MM X 6CM PE F-IDC COIL WERE SELECTED FOR USE. HOWEVER, BOTH DEVICE COULD NOT BE DELIVERED OR WITHDRAWN OUTSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE 2MM X 6CM COIL WAS DETACHED/SEPARATED AT THE INTERLOCKING ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016540 ↗
• MalfunctionJul 21, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED. A 2MM X 6CM AND 3MM X 6CM INTERLOCK WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS EXTREMELY HARD AND WOULD NOT LOOP. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15079347 ↗
• InjuryJun 15, 2022Separation Failure; Material Deformation; Separation Failure; Material Deformation

  IT WAS REPORTED THAT DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT HEPATIC ARTERY. A 2MM X 6CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS DEPLOYED TO FIRST IMPLEMENT EMBO WITH THE A1 NOMAR BRANCH OF RIGHT HEPATIC ARTERY. HOWEVER, IT WAS NOTED THAT THE COIL WIRE WAS NOT DEPLOYED AS THE COIL WIRE WAS KINKED IN THE MICROCATHETER. THUS, THE FIRST ATTEMPTED COIL WAS REMOVED AND DISCARDED. A PRODUCT WITH THE SAME SIZE WAS TRIED AGAIN, HOWEVER WHEN THE DEVICE WAS PUSHED HARD, A VESSEL DISSECTION WAS NOTICED. THE DEVICE WAS REMOVED AND DISCARDED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 14708615 ↗
• MalfunctionSep 20, 2021Separation Failure; Material Integrity Problem; Separation Failure; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE WAS TORN. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL CIRCUMFLEX ILIAC ARTERY. A 2MM X 6CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL DID NOT DETACH. AN ATTEMPT WAS MADE TO PUSH THE DEVICE WITH A 0.021 INCH WIRE, BUT IT COULD NOT BE PERFORMED. THE DEVICE WAS REMOVED TOGETHER WITH THE MICROCATHETER. AFTER PULLING IT OUT, IT WAS NOTED THE DEVICE WAS TORN FURTHER ON THE "HAND SIDE" THAN THE LOCKING ARM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502548 ↗
• MalfunctionAug 4, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP. THE TARGET LESION AREA WAS LOCATED IN THE MODERATELY TORTUOUS ABDOMINAL ARTERY. A 2MM X 6CM INTERLOCK 2MM X 6CM PE-F IDC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF THE CATHETER AND PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE DEVICE WAS REMOVED THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10363702 ↗
• MalfunctionDec 30, 2019Entrapment of Device; Material Protrusion/Extrusion; Entrapment of Device; Material Protrusion/Extrusion

  IT WAS REPORTED THAT COIL PROTRUSION OCCURRED. THE TARGET LESION WAS IN A MODERATELY TORTUOUS LUMBAR ARTERY. A 2MMX6CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL GOT STUCK IN THE MIDDLE PART OF THE MICROCATHETER AND PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9532185 ↗
• MalfunctionDec 9, 2019Premature Activation; Material Protrusion/Extrusion; Premature Activation; Material Protrusion/Extrusion

  IT WAS REPORTED THAT COIL PROTRUSION DURING REMOVAL OCCURRED. THE LESION WAS IN THE INFERIOR MESENTERIC ARTERY. A 2MMX6CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, THE COIL DETACHED INSIDE THE MICROCATHETER AS THE MAIN COIL AND ARM OF THE DELIVERY WIRE GOT SEPARATED. SUBSEQUENTLY, THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER AND WAS NOTED PROTRUDING FROM THE CATHETER'S TIP. 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 9437446 ↗