Interlock™-35 M001363580Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729793045), received between Apr 12, 2019 and May 8, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Stretched” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Stretched; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE COIL WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE HYPOGASTRIC ANEURYSM. A 8MM X 20CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS BEING DEPLOYED AND REPOSITIONED WHEN THE PHYSICIAN EXPERIENCED STRETCHING OF THE COIL. THE DEVICE HAD NOT EXHIBITED ANY ISSUES UPON OPENING AND WAS USED FOR THE FIRST TIME. DURING THE ATTEMPT TO REPOSITION, THE COIL ELONGATED, AND REMOVAL WAS DEEMED THE ONLY VIABLE OPTION. THE COIL WAS SUCCESSFULLY WITHDRAWN FROM THE PATIENT BY PULLING IT OUT ALONG WITH THE DIAGNOSTIC CATHETER. THE PROCEDURE WAS THEN COMPLETED THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED MAIN COIL DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25127982 ↗
• MalfunctionMay 5, 2025Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10APR2025. IT WAS REPORTED THAT THE COIL WOULD NOT ADVANCE OUT IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. AN 8MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL STOPPED AT THE TIP OF THE CATHETER AND WOULD NOT ADVANCE OUT. WHEN ATTEMPTING TO WITHDRAW, THE COIL 'UNWOUND' AND HAD TO PULL THE ENTIRE CATHETER AND COIL TOGETHER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962501 ↗
• MalfunctionJun 20, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. AN 8MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS INTERRUPTED WHEN INSERTED INTO THE CATHETER. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19576168 ↗
• MalfunctionMay 31, 2024Separation Failure; Adverse Event Without Identified Device or Use Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21MAY2024. IT WAS REPORTED THAT THE COIL COULD NOT BE DEPLOYED. AN .035 INTERLOCK COIL WAS SELECTED FOR USE IN A SPLENIC EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE .035 INTERLOCK COULD NOT BE DEPLOYED. THE COIL WAS REMOVED AND EXCHANGED FOR A NEW COIL AND MICROCATHETER. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19440098 ↗
• MalfunctionMay 22, 2024Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. AN 8MM X 20CM INTERLOCK .035 WAS SELECTED FOR USE. THE INTERLOCK DEVICE CONTINUED TO BE DEPLOYED INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376838 ↗
• MalfunctionMar 19, 2024Difficult to Remove; Difficult to Remove

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT WHEN THE FIRST COIL WAS DEPLOYED, IT FELT LIKE IT WAS IN A BAD POSITION AND COULD NOT BE WITHDRAWN. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED PULMONARY ARTERY. AN 8MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE FIRST COIL WAS DEPLOYED, IT FELT LIKE IT WAS IN A BAD POSITION, AND IT COULD NOT BE WITHDRAWN. THE COIL WAS WITHDRAWN WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO COMPLICATIONS WERE REPORTED, 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 18933182 ↗
• InjuryMay 31, 2023Break; Premature Activation; Difficult to Remove; Failure to Advance; Break; Premature Activation; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT COIL DETACHMENT OCCURRED, SNARE WAS ATTEMPTED BUT COIL STILL REMAINED INSIDE THE BODY. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS PULMONARY ARTERY. AN 8MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL DID NOT DEPLOY CORRECTLY. RESISTANCE WAS MET AND THE COIL WAS UNABLE TO PULL OR PUSH TO RECAPTURE THE DEVICE. MOST OF THE COIL WAS PUSHED OUT INTO THE DESIRED LOCATION, HOWEVER, WHEN THE CATHETER WAS PULLED BACK, IT WAS NOTED THAT A STRING OF THE COIL WAS PULLED BACK INTO THE PULMONARY ARTERY. PHYSICIAN'S THOUGHT THAT IT LOOKED LIKE THAT SOME OF THE PUSHER WIRE WAS ON IT TOO BUT IT WAS UNCLEAR. THE COIL WAS TRIED TO BE SNARED OUT BUT IT WAS UNABLE TO AND WAS LEFT INSIDE THE BODY, PATIENT WAS UNDER MONITORING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17033564 ↗
• MalfunctionMar 7, 2023Break; Premature Activation; Stretched; Failure to Advance; Material Integrity Problem; Break; Premature Activation; Stretched; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE INTERLOCKING ARM GOT DETACHED. A 8MMX40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, PHYSICIAN ENCOUNTERED RESISTANCE WHEN INSERTING AND ADVANCING THE COIL INTO THE CATHETER. THE PHYSICIAN TRIED TO RETRACT THE COIL FROM THE CATHETER, BUT THE COIL WAS DEPLOYED INSIDE THE CATHETER. THEREFORE, THE CATHETER WAS REMOVED FROM THE PATIENT AND THE COIL WAS RETRIEVED. AFTER EXAMINING THE COIL IN THE STERILE TABLE, THE INTERLOCKING SYSTEM SEEMS BROKEN, STRETCHED AND CRINKLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496235 ↗
• MalfunctionAug 24, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE CATHETER. AN 8MMX20CM INTERLOCK-35 COIL WAS SELECTED FOR USE IN THE ILIAC ARTERY. DURING THE PROCEDURE, THREE COILS WERE USED, HOWEVER, THE SECOND COIL WAS STUCK IN THE MIDDLE PART OF THE CATHETER WHEN DEPLOYED. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED MAIN COIL INTERLOCKING ARM DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282535 ↗
• MalfunctionMar 14, 2022Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21FEB2022. IT WAS REPORTED THAT THE COIL COULD NOT BE DEPLOYED. A 8MM X 20CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DEPLOYED NORMALLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  MAUDE report 13764688 ↗
• MalfunctionDec 2, 2021Entrapment 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 MODERATELY TORTUOUS AND NON CALCIFIED INTERNAL ILIAC ARTERY. AN 8MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER. FURTHERMORE, WHEN THE COIL WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE MICROCATHETER. THE DEVICE WAS REMOVED TOGETHER WITH THE CATHETER 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 12920663 ↗
• MalfunctionMar 15, 2021Entrapment of Device; Stretched; Detachment of Device or Device Component; Entrapment of Device; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP AND INTERLOCKING BUCKLE FELL OFF. THE MODERATELY STENOSED TARGET LESION AREA WAS LOCATED IN MODERATELY TORTUOUS AND MODERATELY CALCIFIED GASTRIC VEINS. A 8MM X 20CM .035 INTERLOCK EMBOLICS WAS SELECTED FOR USE IN GASTRIC CORONARY VEIN EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT A TOTAL OF THREE COILS WERE USED, HOWEVER, WHEN THIS DEVICE WAS ADVANCED IT COULD NOT BE ADVANCE TO ONE THIRD OF THE WAY AS IT GOT STUCK AND AT THIS TIME, THE PROTECTIVE SHEATH COULD NOT BE RETRIEVED. THE DEVICE WAS SIMPLY PULLED OUT WIH THE COIL PROTRUDING OUT OF THE CATHETER'S TIP UPON REMOVAL FROM THE PATIENT. THE SYSTEM WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. SUBSEQUENTLY AFTER THE PROCEDURE, THE COIL WAS FOUND STRETCHED, AND THE INTERLOCKING BUCKLE FELL OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. IT WAS FURTHER REPORTED THAT THERE WERE NO FIBER BUNDLES LEFT INSIDE THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485125 ↗
• MalfunctionFeb 4, 2021Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE FRACTURED. THE TARGET LESION AREA WAS LOCATED IN THE CORONARY VEINS OF THE STOMACH. A 2D .035 8MMX20CM INTERLOCK .035 EMBOLICS WAS SELECTED FOR USE IN THE EMBOLIZATION OF THE GASTRIC CORONARY VEIN. DURING THE PROCEDURE, THE SECOND COIL WAS ADVANCED A LITTLE AND THE POSITION WAS ADJUSTED BY RE-ADVANCING THE DEVICE. HOWEVER, IT WAS NOTED THAT THE INTERLOCKING ARMS WAS FRACTURED, AND STRETCHED. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279780 ↗
• MalfunctionDec 8, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25NOV2020. IT WAS REPORTED THAT THE COIL WAS UNABLE TO CROSS THE CATHETER. A 10MMX40CM CUBE INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE CATHETER DISTAL PART DESPITE THE OTHER COILS OF SIMILAR BEING FINE. FURTHERMORE, IT WAS NOTED THAT THE COIL COMPLETELY UNRAVELED AND ALMOST WAS UNRETRIEVABLE, AND PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. THIS AFFECTED THE BASE CATHETER AND A 8MM X 20CM INTERLOCK-35 COIL WAS UNABLE TO PASS SO THEY HAD TO REPLACE THE BASE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A LOSS OF FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10971593 ↗
• MalfunctionAug 4, 2020Human-Device Interface Problem; Material Deformation; Human-Device Interface Problem; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21 JUL 2020. IT WAS REPORTED THAT THE COIL COULD NOT BE PULLED OR PUSHED. THE TARGET LESION AREA WAS LOCATED IN THE UPPER GASTROINTESTINAL TRACT. A 8MM X 20CM INTERLOCK-35 EMBOLIC WAS SELECTED FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT. DURING THE PROCEDURE, THE COIL WAS DEPLOYED BUT THE POSITION WAS POOR. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ONCE DEPLOYED BUT THE DEPLOYMENT LOCATION CAN NOT CURE THE PATIENT, SO ADJUSTMENTS WERE DONE TWICE BUT IT COULD NOT BE PULLED NOR PUSHED. IT WAS TRIED SEVERAL TIMES, THE COIL AND THE CATHETER WERE SIMPLY PULLED OUT OF THE PATIENT'S BODY. THEN, IT WAS NOTED THAT THE INTERLOCKING DETACHABLE ARMS WERE KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM AND MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10362403 ↗
• MalfunctionAug 3, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED INTERNAL ILIAC ARTERY. A 8MMX20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF A 5F NON-BSC CATHETER. THE COIL AND CATHETER WERE THEN REMOVED TOGETHER, HOWEVER THE COIL PROTRUDED FROM THE CATHETER'S TIP. 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 10355809 ↗
• MalfunctionNov 1, 2019Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10OCT2019. IT WAS REPORTED THAT THE COIL COULD NOT DEPLOY. AN 8MM X 20CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, A CONTINUOUS FLUSH WAS PERFORMED AND THE DEVICE WAS ADVANCED TO THE MIDDLE OF THE 5F CATHETER; HOWEVER IT WAS NOTED THAT THE DEVICE COULD NOT DEPLOY. THE DEVICE WAS REMOVED WITH THE CATHETER FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES AND THE INTERLOCKING ARM OF THE MAIN COIL WAS DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265957 ↗
• MalfunctionOct 21, 2019Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14OCT2019. IT WAS REPORTED THAT THE COIL WAS DEFORMED. THE TARGET LESION AREA WAS LOCATED IN A MODERATELY TORTUOUS BLOOD VESSEL. A 2D 8MMX20CM INTERLOCK-35 WAS SELECTED FOR A GONADAL VEIN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, A DEFORMITY WAS NOTED ON THE COIL AND IT WAS CONFIRMED THAT THE COIL WAS FRAYED. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED AND WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9214736 ↗
• MalfunctionApr 12, 2019Device Damaged by Another Device; Device-Device Incompatibility; Material Protrusion/Extrusion; Device Damaged by Another Device; Device-Device Incompatibility; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE DEVICE PIERCED THE CATHETER AND ENTERED THE PATIENT. THE TARGET LESION WAS LOCATED IN THE HEPATIC VEIN. A 8MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED THROUGH A 4F NON-BSC ANGIOGRAPHIC CATHETER. THE INTERLOCK DEVICE PIERCED THE OUTSIDE OF THE CATHETER WITH THE PUSHER. ABOUT 45-55MM OF THE COIL HAD BEEN ADVANCED INTO THE PATIENT WHEN THE PHYSICIAN NOTED THIS. THE COIL WAS NOT DEPLOYED/DETACHED FROM THE PUSHER/DELIVERY WIRE. THE COIL WAS ABLE TO BE PULLED OUT OF THE BODY, INTO THE CATHETER, AND REMOVED FROM THE PATIENT. AT THIS POINT, IT SEEMED LIKE ENOUGH COILS HAD BEEN IMPLANTED AND INTERVENTION WAS STOPPED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509040 ↗