Interlock™-35 M001363600Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729793137), received between Sep 5, 2018 and Jun 23, 2025 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 23, 2025Separation 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 26MAY2025. IT WAS REPORTED THAT THE COIL FAILED TO SEPARATE. THE PATIENT UNDERWENT HEPATIC ARTERIAL CHEMOEMBOLIZATION. THE TARGET LOCATION WAS TORTUOUS WITH A MALIGNANT TUMOR IN THE LIVER. A 10MM X 20CM 2D INTERLOCK-35 WAS ADVANCED FOR EMBOLIZATION. DURING THE PROCEDURE, THE COIL ENTERED THE PATIENT'S BODY, BUT THE COIL COULD NOT BE DETACHED. THE DEVICE WAS PULLED OUT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME COIL FOR EMBOLIZATION. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE ARM OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310044 ↗
• InjuryMay 13, 2024Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROTRUDING COIL WAS REMOVED WITH AN ADDITIONAL DEVICE. AN INTERLOCK-35 EMBOLIC COIL WAS SELECTED FOR USE. THE COIL WAS DEPLOYED; HOWEVER, IT WAS PROTRUDING FROM THE TARGET LOCATION. IMAGING REVEALED A RESIDUAL 'THREAD' IN THE RENAL VEIN. THE COIL WAS REMOVED WITH A LASSO. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298419 ↗
• MalfunctionApr 11, 2024Difficult to Advance; Material Protrusion/Extrusion; Difficult to Advance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT COIL PROTRUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 10MM X 20CM 2D INTERLOCK-35 COIL WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, APPROXIMATELY 20 COILS WERE USED, BUT THIS COIL WAS PUSHED BACK FROM THE EMBOLIZATION SPOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE COIL COULD NOT GO IN FURTHER AND WAS REMOVED FROM THE DISTAL AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093393 ↗
• InjuryJan 29, 2024Premature Activation; Stretched; Difficult to Advance; Premature Activation; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE COIL WAS SNARED OUT OF THE PATIENT. A 10MM X 20CM INTERLOCK-35 COIL WAS SELECTED FOR USE IN A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE TO TREAT VARICES. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS DIFFICULT TO PUSH, AND THERE WAS A LOT OF RESISTANCE WHEN TRYING TO DEPLOY THE COIL OUTSIDE THE TIP OF THE MICROCATHETER. CONSEQUENTLY, THE COIL DETACHED EARLY INSIDE THE MICROCATHETER, AND THE COIL BECAME STRETCHED. THE COIL WAS SNARED OUT OF THE PATIENT ONCE THE PHYSICIAN WAS ABLE TO DEPLOY THE COIL THAT WAS STUCK INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597764 ↗
• MalfunctionJan 10, 2024Contamination; Contamination

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A 10MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT A SMALL HAIR WAS PRESENT INSIDE THE PACKAGING. 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 18489773 ↗
• MalfunctionSep 12, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21AUG2023. IT WAS REPORTED THAT THE COIL STUCK HALFWAY AND COULD NOT BE PUSHED OUT. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC ARTERY. A 10MM X 20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER MANY ATTEMPTS OF ADJUSTING, THE COIL COULD NOT ADVANCE AND WAS STUCK HALFWAY THROUGH THE MICROCATHETER AND COULD NOT BE PUSHED OUT. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE THREE COILS USED IN TOTAL. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS CONFIRMED THAT THE MAIN COIL DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732582 ↗
• MalfunctionFeb 1, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL GOT STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, A 10MM X 20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL DID NOT COME OUT OF THE TIP OF THE CATHETER AND COULD NOT BE PUSHED AT ALL. THE DEVICE WAS THEN REMOVED BUT IT COULD NOT BE REMOVED FROM THE CATHETER. THE PHYSICIAN THEN REMOVED THE ENTIRE CATHETER FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280647 ↗
• MalfunctionJul 8, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15JUN2022. IT WAS REPORTED THAT THE COIL GOT STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA AND INTERNAL ILIAC ARTERY. AN 8MM X 40CM AND 10MM X 20CM INTERLOCK-35 COIL WERE SELECTED FOR USE. DURING THE PROCEDURE, THREE INTERLOCKS WERE PLACED SMOOTHLY. HOWEVER, WHEN THE FOURTH CATHETER WAS PUSHED, IT GOT STUCK NEAR THE MIDDLE OF THE CATHETER. THE COIL WAS REMOVED TOGETHER WITH THE ENTIRE CATHETER FROM THE BODY. A NEW INTERLOCK WAS INSERTED TOGETHER WITH THE SAME CATHETER AND COMPLETED THE PROCEDURE. TWO INTERLOCKS WERE IMPLANTED INTO THE BODY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, THE DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED AND THE FIBER BUNDLES WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14959441 ↗
• MalfunctionJun 23, 2022Difficult to Remove; Failure to Advance; Material Integrity Problem; Difficult to Remove; Failure to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26MAY2022. IT WAS REPORTED THAT THE COIL DID NOT ADVANCE INTO THE CATHETER. A 10MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL DID NOT ADVANCE INTO THE CATHETER. ALSO, THE HAIRS ON THE COILS WERE LOOSE AND DEFORMED HAIRS. THE COIL AND CATHETER WERE REMOVED TOGETHER FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO 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 14787004 ↗
• MalfunctionJun 8, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT DEVICE COULD NOT BE PUSHED FURTHER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 10MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED NOR WITHDRAW FROM THE CATHETER AFTER ADVANCING FOR A HALF. BOTH COIL AND CATHETER WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS 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 11957279 ↗
• MalfunctionMay 19, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04MAY2021. IT WAS REPORTED THAT THE COIL WAS STUCK IN INTRODUCER SHEATH. THE TARGET LESION WAS LOCATED IN THE PELVIC VEIN. A 10MMX20CM 2D INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO ADVANCE THE PUSH CABLE, IT DID NOT MOVE, OBSERVING FAILURE IN THE ANCHORING OF THE COIL. IT WAS NOTED THAT THE DEVICE NEVER CAME OUT OF THE PROTECTIVE HYPOTUBE AND WAS NOT PLACED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11851733 ↗
• MalfunctionMay 10, 2021Entrapment of Device; Premature Activation; Physical Resistance/Sticking; Entrapment of Device; Premature Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. A 8MM X 40CM INTERLOCK COIL AND A 10MM X 20CM INTERLOCK COIL WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THERE WAS RESISTANCE FELT DURING DEPLOYMENT OF THE COIL, AND IT COULD NOT BE PUSHED FURTHER. THE PUSHER WIRE WAS PULLED OUT, BUT COIL WAS LEFT DETACHED INSIDE THE 5F NON BOSTON SCIENTIFIC CATHETER. THE SAME EVENT OCCURRED WITH THE SECOND COIL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11800967 ↗
• MalfunctionApr 13, 2021Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05APR2021. IT WAS REPORTED THAT THERE WAS FRICTION AND THE COILS WOULD NOT PASS THE TIP OF THE CATHETER. A10MM X 20CM INTERLOCK .035 EMBOLIC DEVICE WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE, WHILE INSIDE THE PATIENT, THE COILS WOULD NOT PASS THE TIP OF THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE INTERLOCKING ARM WAS DETACHED AND THERE WERE MISSING FIBER BUNDLES. DEVICE EVALUATED BY MFR: VISUAL INSPECTION SHOWED THAT ONLY THE COIL WAS RETURNED FOR THIS COMPLAINT. THE COIL FIBER BUNDLES HAD BLOOD ON THEM. THE MAIN COIL WAS KINKED AND STRETCHED. NO MORE DAMAGES WERE FOUND IN THE RETURNED DEVICE. MICROSCOPIC INSPECTION OF THE MAIN COIL SHOWED THAT THE ZAP TIP HAS A SMOOTH SURFACE. THE INTERLOCKING ARM WAS INSPECTED, AND IT WAS DETACHED. THE MAIN COIL NUMBER OF DISTAL FIBER BUNDLES, ZAP TIP OUTER DIAMETER AND PRIMARY COIL OUTER DIAMETER WERE WITHIN SPECIFICATIONS, EXCEPT FOR THE NUMBER OF PROXIMAL FIBER BUNDLES WHICH WAS 18 OUT OF 22-32.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11657635 ↗
• MalfunctionMar 8, 2021Entrapment of Device; Stretched; Entrapment of Device; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT THE COIL WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE RIGHT RENAL ARTERY. A 10MMX20CM 2D INTERLOCK-35 COIL WAS SELECTED FOR USE. AFTER DEPLOYING THREE COILS SUCCESSFULLY, A FOURTH COIL WAS ADVANCED, THE PHYSICIAN TRIED TO ADJUST ITS POSITION AND WITHDREW IT INTO THE PROTECTION SHEATH. BUT WHEN IT WAS RE-DEPLOYED, THE COIL COULD NOT BE PUSHED FROM THE PROTECTION SHEATH EVEN AFTER TRYING SEVERAL TIMES. THE COIL WAS FOUND STRETCHED AFTER WITHDRAWAL. 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 FIBER LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436707 ↗
• MalfunctionDec 4, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT COIL PROTRUDED FROM THE CATHETER TIP. THE TARGET LESION AREA WAS LOCATED IN A MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 10MM X 20CM INTERLOCK-35 EMBOLIC WAS SELECTED FOR USE IN THE EMBOLIZATION OF AN ANEURYSM IN THE INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, THE COIL GOT STUCK INSIDE THE CATHETER AT THE DISTAL PART. HOWEVER, THE COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE COIL WAS REMOVED AS IT WAS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10949545 ↗
• MalfunctionFeb 12, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS SPILT INTO TWO. A 10MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. THE PROXIMAL END OF THE COIL WAS NOTED TO BE SPLITTING INTO TWO, CONSEQUENTLY PREVENTING THE INSERTION OF THE DEVICE INTO THE INTRODUCER SHEATH. THE PROCEDURE WAS THEN COMPLETED BY CHANGING THE COIL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8331938 ↗
• InjurySep 5, 2018Material Protrusion/Extrusion; Physical Resistance/Sticking; Material Protrusion/Extrusion; Physical Resistance/Sticking

  IT WAS REPORTED THAT VESSEL DISSECTION AND COIL PROTRUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE VENUE SPERMATICA. A 10MMX 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN A NON-BSC CATHETER AND IT WAS UNKNOWN WHETHER IT WAS FLUSHED SUFFICIENTLY; THEY DID FLUSH. BOTH COIL AND CATHETER WERE THEN REMOVED AT ONCE FROM THE SHEATH OUT OF THE PATIENT. HOWEVER, THE COIL WAS PROTRUDING AT THE CATHETER'S TIP UPON REMOVAL AND A DISSECTION OF THE VENA OCCURRED. THERE WAS NO NEED TO REPAIR SINCE THE HEMOSTASIS OF THE BLOOD CAUSED BLOOD CLOTTING, BECAUSE OF WHICH A NATURAL EMBOLI OCCURRED; THAT IS THE REASON THEY DID NOT USED ADDITIONAL PRODUCTS TO FINISH THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 7845693 ↗