Interlock™ M001361500Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729764939), received between Aug 14, 2018 and Oct 27, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL BROKE INSIDE THE CATHETER. A 3MM X 6CM INTERLOCK COIL WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE CORE OF THE COIL BROKE OR FRACTURED INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS OR ADVERSE EVENTS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393443 ↗
• MalfunctionJul 10, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 12JUN2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE. THE STENOSED TARGET LESION WAS IDENTIFIED IN THE LIVER. A 3MM X 6CM INTERLOCK DEVICE WAS CHOSEN FOR THE PROCEDURE. THE PATIENT SUBSEQUENTLY UNDERWENT TUMOR HEMORRHAGIC EMBOLIZATION. DURING THE PROCEDURE, THE SECOND COIL COULD NOT BE PUSHED OUT IN THE PROTECTIVE SHEATH. DESPITE MULTIPLE ATTEMPTS, THE COIL STILL COULD NOT BE PUSHED OUT. THE PROCEDURE WAS COMPLETED USING TWO OF THE SAME COILS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT STATUS POST PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469946 ↗
• MalfunctionMar 21, 2024Difficult to Remove; Stretched; Material Integrity Problem; Difficult to Remove; Stretched; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04MAR2024. IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO COIL UP, WAS DIFFICULT TO PULL, AND THE COIL WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE BRONCHIAL ARTERY. A 3MM X 6CM INTERLOCK WAS SELECTED FOR USE. AFTER THE BLEEDING POINT WAS FOUND BY AN ANGIOGRAPHY CATHETER, A NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED TO PERFORM THE EMBOLIZATION. DURING DEPLOYMENT OF THE COIL, IT WAS NOTED THAT IT WAS DIFFICULT TO COIL UP DUE TO THE RELATIVELY THIN BLOOD VESSEL. THE COIL WAS WITHDRAWN INTO THE SHEATH, AND IT WAS DIFFICULT TO PULL, RESULTING IN THE COIL BEING STRETCHED. THE MICROCATHETER WAS PULLED BACK AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ZAP TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952534 ↗
• MalfunctionSep 20, 2023Break; Premature Activation; Break; Premature Activation

  IT WAS REPORTED THAT THE COIL WAS DETACHED. THE TARGET LESION WAS LOCATED IN THE DIGESTIVE TRACT AREA. A 3MM X 6CM INTERLOCK COIL WAS SELECTED FOR USE. THE DEVICE WAS CONTINUOUSLY FLUSHED BEFORE INTRODUCTION OF THE COIL. DURING THE PROCEDURE, ONE 4 X 12 AND ONE 4 X 8 BOSTON SCIENTIFIC CONTROLLABLE COILS WERE PLACED SUCCESSFULLY. DURING THE PLACEMENT OF THE LAST 3MM X 6CM INTERLOCK COIL, IT WAS NOTED THAT THE COIL AND THE INTERLOCKING ARM WERE DISLODGED. THE COIL AND THE CATHETER WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785201 ↗
• MalfunctionJan 5, 2023Break; Premature Activation; Break; Premature Activation

  IT WAS REPORTED THAT COIL FIBERS DETACHED IN THE SHEATH. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY FISTULA. A 3MM X 6CM PE F-IDC INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THIS DEVICE WAS ADVANCED AND DEPLOYED PREMATURELY IN THE MICROCATHETER. UPON WITHDRAWAL OF THE COIL SOME OF THE FIBERS HAD COLLECTED IN THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109414 ↗
• MalfunctionDec 21, 2022Separation Failure; Malposition of Device; Separation Failure; Malposition of Device

  IT WAS REPORTED THAT THE COIL SEPARATED IN AN UNEXPECTED LOCATION. A 3MM X 6CM F-IDC INTERLOCK WAS SELECTED FOR USE BEFORE EVAR STENT GRAFT PLACEMENT. DURING THE PROCEDURE, WHEN PLACING THE COIL, IT DID NOT SEPARATE FROM THE DELIVERY WIRE SMOOTHLY. FURTHERMORE, WHEN IT WAS TRIED TO BE RETRACTED ONCE, THE CATHETER BOUNCED, AND THE COIL SEPARATED IN AN UNEXPECTED LOCATION IN THE INTERNAL ILIAC ARTERY. NO SPECIAL TREATMENT WAS TAKEN WITH THE PHYSICIAN'S DECISION. 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 16025742 ↗
• MalfunctionJul 24, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATION IN THE INTERNAL ILIAC ARTERY. A 3MMX6CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK INSIDE THE MIDDLE PART OF CATHETER. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AND PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15090514 ↗
• 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 15079450 ↗
• MalfunctionMay 19, 2022Premature Activation; Stretched; Failure to Advance; Premature Activation; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21APR2022. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED SMOOTHLY, DETACHED ON ITS OWN AND WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE LEFT GASTRIC ARTERY. A 3MMX6CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICRO-CATHETER WAS ADVANCED TO THE BLEEDING SITE, A Y-VALVE WAS CONNECTED AND AN INTERLOCK COIL WAS ADVANCED, BUT IT COULD NOT BE DELIVERED SMOOTHLY. AFTER MULTIPLE DELIVERY, THE COIL DETACHED ON ITS OWN AND WAS STRETCHED. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435275 ↗
• MalfunctionJan 14, 2022Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP WHEN REMOVED. THE TARGET LESION WAS LOCATED IN THE INFERIOR MESENTERIC ARTERY. A 3MM X 6CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MAIN COIL AND THE ARM OF THE DELIVERY WIRE WERE PREMATURELY DETACHED IN THE MIDDLE PART OF THE CATHETER. ONLY THE COIL WAS PULLED OUT. HOWEVER, IT WAS NOTED THAT THE COIL WAS PROTRUDED FROM THE CATHETER TIP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261386 ↗
• MalfunctionDec 15, 2021Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT THE COIL TIP MOVED OUT OF CATHETER. A 3MM X 6CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP WAS MOVED OUT OF CATHETER ABOUT 0.5CM WHEN COIL WAS DEPLOYED. THE CATHETER WAS PULLED BACK BECAUSE THE RECEDING POSITION OF THE CATHETER WAS NOT IDEAL, BUT IT COULD NOT BE PULLED BACK NOR BE PUSHED OUT. THE MICROCATHETER WAS WITHDRAWN WITH THE COIL PROTRUDING FROM THE CATHETER TIP AND PROCEDURE WAS COMPLETED WITH A NEW CATHETER AND THE COIL COULD BE DEPLOYED. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13015106 ↗
• MalfunctionSep 21, 2021Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30AUG2021. IT WAS REPORTED THAT DEVICE WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 3MM X 6CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL GOT STUCK IN THE CATHETER AND PREMATURELY DEPLOYED IN THE PROTECTIVE SHEATH. THE DEVICE SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME. A TOTAL OF 2 COILS WERE USED IN THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED AND THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507170 ↗
• MalfunctionJul 29, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN METAL WAS DETACHED FROM THE PROTECTIVE SHEATH. A 3MMX6CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, EMBOLIZATION WAS PERFORMED WITH A TOTAL OF THREE FREE COILS AND ONE CONTROLLABLE COIL WERE USED. CONSEQUENTLY, AFTER OPENING THE PACKAGE OF THE 3MMX6CM COIL, IT WAS FOUND THAT A FOREIGN METAL DETACHED FROM THE PROTECTIVE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247569 ↗
• MalfunctionJun 3, 2021Premature Activation; Premature Activation

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT THE COIL DETACHED BEFORE BEING PLACED IN THE DESIRED LOCATION. A 3MMX6CM INTERLOCK WAS SELECTED FOR USE IN A VASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE COIL DETACHED BEFORE BEING PLACED IN THE DESIRED LOCATION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11931331 ↗
• MalfunctionMay 11, 2021Separation Failure; Material Integrity Problem; Separation Failure; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20APR2021. IT WAS REPORTED THAT THE COIL COULD NOT BE DEPLOYED. A 3MMX6CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, MULTIPLE COILS WERE USED HOWEVER THIS DEVICE COULD NOT BE DEPLOYED ALL THE TIME. SUBSEQUENTLY, THE DEPLOY CLASP WAS PARTIALLY FIXED AND COULD NOT BE DEPLOYED WHEN WITHDRAWN FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM AND NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809936 ↗
• MalfunctionMay 11, 2021Detachment of Device or Device Component

  COIL DETACHED BEFORE BEING PLACED IN THE DESIRED LOCATION DURING AN EMBOLIZATION.

  Patient problems: Insufficient Information

  MAUDE report 11805381 ↗
• MalfunctionMay 5, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21APR2021. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED. A 3MM X 6CM INTERLOCK COIL WAS SELECTED FOR USE TO TREAT RUPTURED DISTAL BRANCH OF THE ARTERIA MESENTERICA SUPERIOR. DURING PROCEDURE, THE COIL ENTERED THE CATHETER, BUT IT COULD NOT BE PUSHED FROM THE CATHETER. THE COIL AND CATHETER WERE WITHDRAWN AND THE PHYSICIAN TRIED AGAIN; HOWEVER IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780637 ↗
• InjuryMar 3, 2020Break; Entrapment of Device; Break; Entrapment of Device

  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 8CMX3MM 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. A 2MMX4CM INTERLOCK WAS THEN USED AND ADVANCED THROUGH THE CATHETER. THE 2MMX4CM INTERLOCK PREMATURELY DEPLOYED WITHIN THE CATHETER AND POSSIBLY TORE WITHIN THE CATHETER DURING REMOVAL. 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.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9782170 ↗
• MalfunctionJan 13, 2020Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23DEC2019. IT WAS REPORTED THAT DIFFICULTY ADVANCING THE COIL THROUGH THE GUIDE CATHETER OCCURRED. THE TARGET LESION AREA WAS LOCATED IN THE PROXIMAL AND MIDDLE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3MM X 6CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, GUIDEWIRES WERE INSERTED DEEPLY INTO CORONARY ARTERY THROUGH THE GUIDING CATHETER. FORCE WAS USED TO DELIVER THE GUIDE CATHETER. THE COIL COULD NOT REACH THE SPIRAL FISTULA THROUGH THE MICRO CATHETER. THE PHYSICIAN TRIED TO CUT, BUT IT FAILED TO REACH TO THE FISTULA PART. ANOTHER OF THE SAME DEVICE WAS SELECTED BUT ALSO FAILED. THE COIL WAS REMOVED WITHIN THE CATHETER ALL TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED ZAP TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9582122 ↗
• MalfunctionAug 29, 2019Entrapment of Device; Separation Failure; Entrapment of Device; Separation Failure

  IT WAS REPORTED THAT THE COIL WAS STUCK ON THE MICROCATHETER TIP UPON WITHDRAWAL. A 3MMX6CM INTERLOCK WAS USED TOGETHER WITH A RENEGADE CATHETER IN A PULMONARY EMBOLISM. DURING THE PROCEDURE, IT WAS NOTED THAT THE PUSHER WIRE ARM COULD NOT BE RELEASED LEADING TO THE COIL BEING STUCK IN THE TIP OF THE MICROCATHETER WHEN WITHDRAWN FOR A PERIOD OF TIME. THE PHYSICIAN WAS FINALLY ABLE TO PULL THE COIL INTO THE RENEGADE AND IT WAS SIMPLY REMOVED FROM THE PATIENT WITH THE COIL INSIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944051 ↗
• MalfunctionOct 9, 2018Component Missing; Activation, Positioning or Separation Problem; Component Missing; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE COIL WAS MISSING UPON REMOVAL. A 3MM X 6CM INTERLOCK COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE IN THE HEAD AND NECK. DURING THE PROCEDURE, WHEN THE DELIVERY SYSTEM WAS ADVANCED THROUGH THE DIREXION CATHETER, THE PHYSICIAN COULD NOT VERIFY IF THE COIL WAS DETACHED. WHEN ATTEMPTING TO DETACH THE COIL AT THE TARGET SITE, DETACHMENT WAS NOT OBSERVED. HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED IT WAS NOTED THAT THE COIL WAS MISSING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7947980 ↗
• MalfunctionAug 14, 2018Separation Failure; Material Protrusion/Extrusion; Separation Failure; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THERE WAS COIL PROTRUSION FROM THE CATHETER'S TIP DURING REMOVAL. A 3MM X 6CM 2D F-IDC INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL FAILED TO RELEASE. FURTHERMORE, DURING REMOVAL OF THE DEVICE, THE COIL PROTRUDED FROM THE CATHETER'S TIP. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7783107 ↗