Interlock™ M001361590Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729765028), received between Oct 25, 2018 and Oct 10, 2024 — classified as 1 injury, 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17 SEP 2024. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. A 10MM X 20CM INTERLOCK COIL WAS SELECTED FOR EMBOLIZATION OF PULMONARY ARTERY FISTULA. DURING THE PROCEDURE, WHEN THE COIL WAS ADVANCED TO THE TAIL END, IT WAS NOTED THAT THE COIL WAS STUCK IN THE MICROCATHETER, AND IT COULD NOT BE ADVANCED DURING THE WITHDRAWAL. THE COIL WAS WITHDRAWN FROM THE PATIENTS BODY TOGETHER WITH THE MICROCATHETER, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THE MAIN COIL WAS DETACHED AT PRIMARY COIL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416860 ↗
• MalfunctionApr 5, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS NOTED THAT THE COIL BROKE DURING DEPLOYMENT. A 10MM X 20CM INTERLOCK WAS USED IN THE NON CALCIFIED SPLENIC ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL KINKED AND BROKE WHILE DEPLOYMENT. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686476 ↗
• InjuryDec 1, 2022Migration; Migration

  IT WAS REPORTED THAT THE COIL PACK MIGRATED. A 10MM X 20CM INTERLOCK-18 FIBERED INTERLOCKING DETACHABLE COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A SPLENIC ARTERY ANEURYSM. NEAR THE END OF THE PROCEDURE, THE COIL PACK MIGRATED DOWNSTREAM AT LEAST 5CM DISTALLY IN THE SPLENIC ARTERY. THE COIL PACK CONTAINED NINE COILS. ALL DEVICES WERE LEFT INSIDE THE PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION. TISSUE NECROSIS OCCURRED, AND THE PATIENT WAS TREATED FOR ACUTE PANCREATITIS. THE PATIENT WAS ULTIMATELY DISCHARGED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Embolism/Embolus; Necrosis; Pancreatitis

  MAUDE report 15900258 ↗
• MalfunctionOct 26, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06OCT2022. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED. A 10MM X 20CM INTERLOCK COIL WAS SELECTED FOR USE IN A SPLENIC ARTERY ANEURYSM. DURING THE PROCEDURE, THE COIL COULD NOT BE DELIVERED. THE ISSUE COULD NOT BE RESOLVED DESPITE REPEAT FLUSHING AND EXCHANGING THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED PUSHER WIRE AND MISSING COIL FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15676548 ↗
• MalfunctionJan 8, 2021Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21DEC2020. IT WAS REPORTED THAT THE DEVICE DID NOT COME LOOSE AND WAS STUCK. A 10MMX20CM INTERLOCK WAS SELECTED FOR USED. DURING PROCEDURE, THE DEVICE DID NOT COME LOOSE FROM THE LOCK UPON RELEASING AND IT WAS STUCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A BROKEN PUSHER WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11139036 ↗
• MalfunctionJul 17, 2020Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL APPROACH. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT INTERNAL ILIAC ARTERY. A 10MMX20CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, TWO 14MMX30CM AND TWO 12MMX30CM COILS WERE PLACED AFTER THE LESION WAS ACCESSED. SUBSEQUENTLY, THE 10MMX20CM COIL WAS ADVANCED AND SLIGHTLY EXTENDED FROM THE MICRO CATHETER. THE EXTENDED COIL FROM THE CATHETER COULD NOT BE PULLED IN ATTEMPT TO PERFORM RECOIL AND COIL WAS JUDGED TO HAVE BEEN DETACHED. BOTH COIL AND MICROCATHETER WERE REMOVED TOGETHER FROM THE PATIENT'S BODY. HOWEVER, THE DISTAL END OF THE COIL WAS NOTED TO BE SLIGHTLY PROTRUDING FROM THE MICROCATHETER TIP UPON REMOVAL. A NON-BSC MICROCATHETER WAS USED TO ACCESS AGAIN THE LESION AND PLACED THREE 10MMX20CM, ON 8MMX20CM AND THREE 6MMX20CM, AND COMPLETED THE PRCOEDURE. NO COMPLICATIONS REPORTED AND PATIENT WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10288721 ↗
• MalfunctionJul 2, 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 INTERNAL ILIAC ARTERY. A 10MMX20CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER. FURTHERMORE, WHEN THE COIL WAS REMOVED FROM THE PATIENTS BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE MICROCATHETER. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224910 ↗
• MalfunctionDec 10, 2019Premature Activation; Material Protrusion/Extrusion; Premature Activation; Material Protrusion/Extrusion

  IT WAS REPORTED THAT COIL PROTRUSION OCCURRED. THE TARGET LESION WAS IN A MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERY. A 10MMX20CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, THE COIL DETACHED INSIDE THE MICROCATHETER AS THE MAIN COIL AND DELIVERY ARM BECAME SEPARATED. THE DEVICE WAS THEN REMOVED TOGETHER WITH THE MICROCATHETER, HOWEVER THE COIL WAS PROTRUDING FROM THE CATHETER'S 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 9444307 ↗
• MalfunctionOct 25, 2018Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE LOCKING ARM WAS SEPARATED THE TARGET LESION WAS LOCATED AT MODERATELY TORTUOUS CELIAC. A 10MM/20CM INTERLOCK DEVICE WAS SELECTED FOR EMBOLIZATION OF THE CELIAC. DURING THE PROCEDURE, THE DEVICE WAS ATTEMPTED TO BE DELIVERED USING A NON BSC MICROCATHETER, BUT IT WAS UNABLE TO BE PUSHED INTO THE CATHETER, SO IT WAS REMOVED FROM THE PATIENT'S BODY. IT WAS SUSPECTED THAT THE COIL WAS DEFECTIVE, SO THE PROCEDURE WAS CONTINUED AFTER REPLACING THE COIL WITH ANOTHER OF THE SAME (THIS COMPLAINT DEVICE). HOWEVER, THE SECOND COIL BECAME STUCK AND COULDN'T BE PUSHED WHEN IT WAS STARTED TO COIL UP SLIGHTLY IN THE CELIAC. WHEN THE COIL WAS ATTEMPTED TO BE PULLED BACK, THE INTERLOCKING ARM OF THE COIL DETACHED FROM THE INTERLOCKING ARMS OF THE PUSHER WIRE DUE TO THE DEVICE BEING PULLED FORCIBLY WHILE IT WAS STUCK. THE MICROCATHETER WAS REMOVED. THE COIL DID NOT REMAIN INSIDE THE PATIENT; IT WAS REMOVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICES. NO COMPLICATIONS REPORTED AND PATIENT'S CONDITION IS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006265 ↗