Interlock™ M001361550Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729764984), received between Oct 17, 2018 and Apr 21, 2026 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27MAR2026. IT WAS REPORTED THAT DEVICE UNABLE TO ADVANCE AND STRETCHED OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARM. A 5MM X 15CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT OF THE SHEATH. UPON REMOVAL, THE COIL WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BROKEN PUSHER WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939785 ↗
• MalfunctionDec 15, 2025Premature Activation; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19NOV2025. IT WAS REPORTED THAT UNABLE TO ADVANCE IN CATHETER AND STRETCHED OCCURRED. THE PATIENT UNDERWENT PELVIC ENDOVENOUS ISOLATION EMBOLIZATION LOCATED IN THE OVARIAN VEIN. A 5MM X 15CM PE F-IDC WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE THIRD INTERLOCK WAS USED TO PUSH FORWARD, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED AND DEPLOYED AT THE END OF THE BSC MICROCATHETER. SEVERAL ATTEMPTS FAILED, AND WHEN THE COIL WAS PULLED BACK, THE COIL WAS STRETCHED DUE TO GREAT RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED AN ARM COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810176 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT THE COIL WAS FRACTURED. A 5MM X 15CM INTERLOCK? COIL WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE COIL FRACTURED INSIDE THE MICROCATHETER DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895093 ↗
• MalfunctionAug 28, 2023Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT A COIL PROTRUSION OCCURRED. THE NON-STENOSED TARGET LESION WAS IN A SEVERELY TORTUOUS AND NON-CALCIFIED INFERIOR MESENTERIC ARTERY. A 5MM X 15CM AND A 4MM X 15CM PE F-IDC INTERLOCK WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT COIL GOT STUCK IN THE DISTAL PART OF THE CATHETER AND PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. ONLY THE COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633185 ↗
• MalfunctionJul 31, 2023Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JUL2023. IT WAS REPORTED THAT THE COIL DEPLOYED IN THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 5MM X 15CM F-IDC 2D COIL WAS SELECTED FOR EMBOLIZATION. DURING THE PROCEDURE, THE COIL GOT DETACHED IN THE DIREXION MICROCATHETER HUB. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED IN THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430181 ↗
• InjuryJun 28, 2023Break; Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THIN COIL FILAMENT SNAPPED AND REMAINED INSIDE PATIENT. A 5MM X 15CM PE F-IDC COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN DEPLOYING THE DEVICE, IT WAS NOTED THAT THE COIL UNRAVELED, AND IT WAS THEN DIFFICULT TO REMOVE. CONSEQUENTLY, THIS LEFT A THIN COIL FILAMENT WHICH SNAPPED WITH THE REMAINING COIL ATTACHED TO THE PUSHER. THE DEVICE WAS REMOVED TOGETHER WITH THE CATHETER. THE REMAINDER OF THE THIN COIL FILAMENT WAS SEEN IN THE EMBOLIZED ARTERY. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17221025 ↗
• MalfunctionDec 14, 2022Difficult 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 22NOV2022. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SPERMATIC VEIN. AFTER A 0.021 MICROCATHETER WAS PLACED, A 5MM X 15CM PE F-IDC 2D COIL WAS DELIVERED IN THE MICROCATHETER BUT THE COIL GOT STUCK IN THE OPENING AND COULD NOT BE PUSHED OUT. THE COIL WAS PULLED BACK WITH THE MICROCATHETER. 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 THE INTERLOCKING ARM WAS FOUND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976160 ↗
• InjuryDec 1, 2022Migration; Migration

  IT WAS REPORTED THAT THE COIL PACK MIGRATED. A 5MM X 15CM 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 15900260 ↗
• MalfunctionFeb 3, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JAN2022. IT WAS REPORTED THAT THE DELIVERY SYSTEM COULD NOT ADVANCE THE COIL. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 5MM X 15CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DELIVERY SYSTEM COULD NOT ADVANCE THE COIL. 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 13442885 ↗
• MalfunctionAug 13, 2020Entrapment of Device; Entrapment of Device

  IT WAS NOTED THAT A COIL PROTRUSION OCCURRED. A 5MM X 15CM INTERLOCK EMBOLIC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK INSIDE THE DISTAL PART OF THE CATHETER. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER. HOWEVER, THE COIL PROTRUDED FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10401767 ↗
• MalfunctionMay 26, 2020Entrapment of Device; Physical Resistance/Sticking; Entrapment of Device; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05MAY2020. IT WAS REPORTED THAT THERE WAS RESISTANCE IN PUSHING THE COIL AND GOT STUCK ON THE SHEATH. THE TARGET LESION WAS LOCATED IN THE SPLENIC VEIN. A 5MMX15CM INTERLOCK WAS SELECTED FOR USE. UPON INTRODUCTION, RESISTANCE WAS NOTED UPON PUSHING THE COIL FROM ITS SHEATH INTO THE IMAGER CATHETER AFTER FLUSHING. SUBSEQUENTLY, THE COIL STUCK IN ITS SHEATH AND COULD NOT BE DELIVERED INTO THE CATHETER. THE DEVICE WAS THEN REMOVED, AND THE PROCEDURE WAS CONTINUED USING ANOTHER DEVICE OF THE SAME SIZE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED INTERLOCKING ARM DETACHED AND MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10087813 ↗
• MalfunctionMay 11, 2020Entrapment of Device; Premature Activation; Material Protrusion/Extrusion; Entrapment of Device; Premature Activation; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL PROTRUDES FROM THE CATHETER'S TIP UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ABDOMINAL VESSEL. A 5MMX15CM INTERLOCK WAS SELECTED FOR USE TO TREAT AN AORTIC ABDOMINAL ANEURYSM. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER AS THE ARM OF THE MAIN COIL AND DELIVERY WIRE GOT SEPARATED. THE DEVICE WAS REMOVED TOGETHER WITH THE MICROCATHETER HOWEVER, THE COIL PROTRUDED FROM THE CATHETER'S TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10043979 ↗
• MalfunctionMay 4, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT COIL PROTRUDED FROM THE CATHETER TIP DURING REMOVAL. THE TARGET LESION AREA WAS LOCATED A MODERATELY TORTUOUS ABDOMINAL ARTERY. A 5MM X 15CM 2D INTERLOCK EMBOLIC WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. SUBSEQUENTLY, THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER AND IT WAS NOTED PROTRUDING FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10021149 ↗
• MalfunctionApr 14, 2020Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31MAR2020. IT WAS REPORTED THAT DEVICE STUCK IN THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 5MM X 15CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT COIL GOT STUCK IN THE DISTAL PART OF THE MICROCATHETER AND WAS REMOVED AS PER USUAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957708 ↗
• MalfunctionFeb 11, 2020Difficult to Flush; Difficult to Flush

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20JAN2020. IT WAS REPORTED THAT THE COIL FAILED TO FILL IN LIQUID. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY FISTULA. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL FAILED TO FILL IN LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT'S CONDITION WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED MISSING COIL FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9694788 ↗
• InjuryDec 9, 2019Premature Activation; Difficult to Remove; Premature Activation; Difficult to Remove

  IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO REMOVE AND WAS SNARED. A 5MM X 15CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS DETACHED INSIDE THE RENEGADE STC CATHETER AND WAS UNABLE TO BE REMOVED FROM INSIDE THE PATIENT. THE COIL WAS REMOVED WITH A SNARE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9439518 ↗
• MalfunctionOct 17, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-OCT-2018. IT WAS REPORTED THAT THE COIL REMAINED INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 5MM/15CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COILS WERE LOADED INTO THE MICROCATHETER; HOWEVER, THE COIL BECAME STUCK AT THE HUB AND WAS NOT DEPLOYED. THE COIL WAS THEN COMPLETELY REMOVED FROM THE PATIENT'S BODY WITHOUT PROTRUSION NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM OF THE COIL AND ZAP TIP WAS DETACHED AND NOT RETURNED; ALSO, THERE MISSING FIBER BUNDLES. IT WAS FURTHER REPORTED THAT THE DEFECTIVE COIL WAS DETACHED AND JAMMED INSIDE THE MICROCATHETER AND THAT THE WHOLE PRODUCTS WERE REMOVED FROM THE PATIENT'S BODY COMPLETELY WITHOUT ADDITIONAL INTERVENTION. THE DEVICE WAS RETURNED FOR ANALYSIS. A PUSHER WIRE, COIL AND INTRODUCER SHEATH WERE RETURNED FOR THIS COMPLAINT. THE COIL AND PUSHER WIRE ARMS WERE NOT INTERLOCKED, DUE TO THE INTERLOCKING ARM OF THE COIL WAS DETACHED FROM THE COIL; THE INTERLOCKING ARM WAS RETURNED TOGETHER WITH THE DEVICE. THE INTRODUCER SHEATH WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7974581 ↗