Interlock™-35 M001363520Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729792987), received between Dec 18, 2018 and Aug 6, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2024Premature Activation; Difficult to Remove; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Difficult to Remove; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15JUL2024. IT WAS REPORTED THAT ADVANCING ISSUE AND PREMATURE DEPLOYMENT OCCURRED. A 4MM X 10CM INTERLOCK-35 COIL WAS SELECTED FOR ARTERIOVENOUS FISTULA FISTULOPLASTY. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE COIL THROUGH A DIAGNOSTIC CATHETER. HOWEVER, WHILE DEPLOYING THE COIL, THE PHYSICIAN ENCOUNTERED RESISTANCE AND REALIZED HALFWAY THROUGH THAT THE COIL HAD ALREADY BEEN DEPLOYED INSIDE THE CATHETER. UNABLE TO RETRACT THE COIL, THE DOCTOR DECIDED TO PULL OUT THE ENTIRE DIAGNOSTIC CATHETER ALONG WITH THE COIL. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923373 ↗
• MalfunctionJun 10, 2024Premature 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 (B)(6) 2024. IT WAS REPORTED THAT COIL DETACHMENT OCCURRED. THE PATIENT WAS IN A SUPINE POSITION AND UNDERWENT A LEFT RENAL ARTERY ANEURYSM PROCEDURE LOCATED IN THE RIGHT FEMORAL ARTERY. THE ARTERY WAS PUNCTURED WITH A MICRO-PUNCTURE NEEDLE INSERTED INTO A 4F SHORT SHEATH. THE CATHETER WAS INSERTED INTO THE ABDOMINAL AORTA AT THE 12TH THORACIC VERTEBRA LEVEL. A NON-BOSTON SCIENTIFIC CATHETER WAS USED TO CHECK ON THE LEFT RENAL ARTERY OPENING WHERE THE GUIDEWIRE WAS FOLLOWED INTO THE DISTAL END. A SINGLE CURVED CATHETER AND HYDROPHOBIC-COATED GUIDEWIRE WERE REPLACED. THE GUIDEWIRE AND THE TIP OF THE CATHETER WERE INSERTED INTO THE ANEURYSM BODY AND THE CATHETER POSITION WAS CONFIRMED BY HAND ANGIOPLASTY. A 6MM X 10CMM, 4MM X 15CM, 4MM X 10CM, AND 5MM X 15CM INTERLOCK-35 COILS WERE SENT FOR DEPLOYMENT. DURING THE PROCEDURE, THE 4MM X 10CM COIL WAS RELEASED INSIDE THE CATHETER. THE PHYSICIAN REPLACED IT WITH A 6MM X 10CM COIL. THE EMBOLIZATION PROCESS WAS SMOOTH AND SUCCESSFUL. AFTER THE PROCEDURE, THE ANEURYSM WAS CONFIRMED BY ANGIOGRAPHY TO HAVE DISAPPEARED. THERE WERE NO COMPLICATIONS REPORTED, AND PATIENT WAS RETURNED TO THE WARD SA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499869 ↗
• MalfunctionOct 27, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. TWO 4MMX10CM INTERLOCK COILS WERE SELECTED FOR USE. DURING THE PROCEDURE, THE COIL GOT STUCK IN THE MIDDLE PART OF THE CATHETER. ONLY THE COIL WAS PULLED OUT AND THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681781 ↗
• MalfunctionOct 27, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. TWO 4MMX10CM INTERLOCK COILS WERE SELECTED FOR USE. DURING THE PROCEDURE, THE COIL GOT STUCK IN THE MIDDLE PART OF THE CATHETER. ONLY THE COIL WAS PULLED OUT AND THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER REASON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681718 ↗
• MalfunctionApr 5, 2022Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15MAR2022. IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO INSERT. A 4MMX10CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS DIFFICULT TO INSERT IN THE CATHETER HUB PART. THE COIL WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017953 ↗
• MalfunctionJan 14, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. A 4MMX10CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE DEVICE THAT ARRIVED WAS CHECKED, A BLOOD-LIKE STAIN SEEMED TO HAVE ADHERED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261332 ↗
• MalfunctionJan 14, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. A 4MMX10CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE DEVICE THAT ARRIVED WAS CHECKED, A BLOOD-LIKE STAIN SEEMED TO HAVE ADHERED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261317 ↗
• MalfunctionMar 31, 2021Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10MAR2021. IT WAS REPORTED THAT THE COIL PREMATURELY DETACHED. A 4MM X 10CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, THE COIL DETACHED EARLY WHILE ADVANCING INSIDE A 5FR CATHETER PRIOR TO IMPLANTATION. THE CATHETER WAS REMOVED WITH COIL INSIDE AND REGAIN ACCESS TO THE PORTAL VEIN. PUSHABLE COILS WERE USED WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM AND INCOMPLETE FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600205 ↗
• MalfunctionSep 9, 2020Premature Activation; Stretched; Detachment of Device or Device Component; Positioning Problem; Physical Resistance/Sticking; Premature Activation; Stretched; Detachment of Device or Device Component; Positioning Problem; Physical Resistance/Sticking

  IT WAS REPORTED THE COIL PROTRUDED FROM THE CATHETER TIP. THE TARGET LESION AREA WAS LOCATED IN A MILDLY TORTUOUS INFERIOR MESENTERY ARTERY (IMA). A 4MMX10CM INTERLOCK 0.35 EMBOLIC COIL WAS SELECTED FOR USE IN AN ENDOVASCULAR ANEURYSM REPAIR. IMA WAS ACCESSED USING A NON-BSC ANGIOGRAPHIC CATHETER. EMBOLIZATION WAS STARTED WITH THE INTERLOCK35 AND WAS SUCCESSFUL UNTIL MIDWAY OF THE SECOND DEVICE WHERE A KINK ON THE NON-BSC ANGIOGRAPHIC CATHETER WAS OBSERVED. THE DELIVERY WAS STARTED, AND WHEN THE COIL CAME OUT ABOUT 5 CM FROM THE TIP OF THE CATHETER, KINK WAS SIGNIFICANTLY OBSERVED THAN BEFORE ALONG WITH A KICKBACK OF THE CATHETER. HOWEVER, THE INTERLOCKING ARM PART BECAME CAUGHT IN THE KINK. ALTHOUGH THE DISTAL PART OF THE COIL WAS PLACED INTO IMA, EARLY DETACHMENT OCCURRED AS IT WAS PUSHED. IT WAS ATTEMPTED TO PUSH THE COIL WITH A NON-BSC GUIDEWIRE TO COME IT OUT OF THE CATHETER, BUT THE COIL WAS UNRAVELED IN THE MIDDLE OF THE CATHETER AND THE UNRAVELED COIL WAS PROTRUDED FROM THE TIP OF THE CATHETER INTO THE AORTA. COIL USAGE WAS STOPPED AS THE GRAFT WAS PLACED. SUBSEQUENTLY, FRAGMENT LIKE THIN WIRE WAS OBSERVED. THE COIL ON THE PROXIMAL SIDE WAS STILL IN THE CATHETER, THE CATHET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10510461 ↗
• MalfunctionMay 1, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL PROTRUDES FROM THE CATHETER TIP. VASCULAR ACCESS WAS OBTAINED VIA IPSILATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS INTERNAL ILIAC ARTERY. THREE INTERLOCK-35 COILS (10MMX40CM, 12MM X 40CM, 4MM X 10CM) WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICES GOT STUCK IN THE DISTAL PART OF THE 5FR IMAGER CATHETER. THE DEVICES WERE THEN REMOVED TOGETHER 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 10016999 ↗
• MalfunctionFeb 26, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. FOUR INTERLOCK-35 COILS WERE USED FOR TREATMENT (4MMX10CM, 6MMX20CM, 12MMX40CM AND 10MMX40CM). DURING THE PROCEDURE, THE COILS WERE STUCK INSIDE THE DISTAL PART OF THE IMAGER CATHETER AND WAS NOTED PROTRUDING FROM THE CATHETER TIP UPON REMOVAL. THE DEVICES WERE NORMALLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9757825 ↗
• MalfunctionFeb 10, 2020Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT COIL PROTRUSION OCCURRED. THE TARGET LESION AREA WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED INTERNAL ILIAC ARTERY. A 4MM X 10CM INTERLOCK -35 COIL WAS SELECTED FOR USE IN A VASCULAR EMBOLIZATION. DURING THE PROCEDURE, EARLY DETACHMENT OCCURRED INSIDE THE MICROCATHETER, THE MAIL COIL AND DELIVERY WIRE ARM GOT SEPARATED. THE DEVICE WAS REMOVED TOGETHER WITH THE MICROCATHETER. IT WAS NOTED THAT THE COIL WAS PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9687380 ↗
• MalfunctionJan 13, 2020Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23DEC2019. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE MICROCATHETER. THE TARGET LESION WAS IN A SEVERELY TORTUOUS RIGHT INTERNAL ILIAC ARTERY. A 4MMX10CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE MICROCATHETER AND THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED DETACHED INTERLOCKING ARM AND LACKING COIL FIBER BUNDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9581504 ↗
• MalfunctionDec 18, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL BECAME STUCK. A 035 INTERLOCK 2D 4MM X 10CM WAS THE SEVENTH COIL USED FOR AN INTERNAL ILIAC ARTERY EMBOLIZATION PROCEDURE. THE LESION ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. THE COIL WAS ADVANCED THROUGH A TERUMO 4F CATHETER WITH CONTINUOUS FLUSH. THE COIL WAS APPROXIMATELY 20CM OUT FROM THE CATHETER WHEN IT BECAME STUCK. IT COULD NOT BE PUSHED OR PULLED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175757 ↗