Interlock™ M001361620Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729765059), received between Oct 18, 2019 and Jun 18, 2026 — classified as 1 injury, 17 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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Migration

  IT WAS REPORTED THAT COIL PACK MIGRATION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED SUBCLAVIAN VESSEL. A 12 MM X 30 CM INTERLOCK WAS SELECTED FOR USE. THE COIL PACK WAS INITIALLY SUCCESSFULLY IMPLANTED. THE PATIENT WAS BROUGHT TO THE CARDIAC INTENSIVE CARE UNIT (CICU), HAD AN X-RAY AND IT WAS NOTED THAT THE COIL MIGRATED TO THE BRONCHIAL ARTERY DUE TO AN ANTEROGRADE FLOW LIKELY CAUSED BY THE STENT GRAFT. THE PATIENT RETURNED THE FOLLOWING DAY, ONE DAY POST OP AND THE COIL PACK WAS SUCCESSFULLY REMOVED VIA SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25549314 ↗
• MalfunctionMay 7, 2026Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY (IIA). A 12MM X 30CM PE F-IDC COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS INSERTED INTO THE CATHETER. HOWEVER, THE COIL WAS UNABLE TO PASS THE ANGULATION OF IIA DUE TO TORTUOSITY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117948 ↗
• MalfunctionSep 17, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT COIL MIGRATION OCCURRED. THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO THE DISCOVERY OF A LEFT FOOT MASS. AFTER COMPLETING NECESSARY EXAMINATIONS AND THE PATIENT WAS UNDER MODERATE SEDATION, A 12MM X 30CM PE F-IDC WAS SELECTED FOR LEFT LOWER EXTREMITY ARTERIOGRAPHY WITH COIL EMBOLIZATION PROCEDURE TO TREAT A VASCULAR ANEURYSM CAVITY. DURING THE PROCEDURE, A 2.7F NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED TO DEPLOY THE COIL. AS A RESULT, THE INTERLOCK ARM OF THE COIL WAS UNLOCKED, AND THE COIL WAS DISLODGED WITHIN THE MICROCATHETER. THE COIL'S OWN GUIDEWIRE WAS WITHDRAWN, LEAVING THE COIL STILL WITHIN THE CATHETER. THE COIL WAS THEN FLUSHED OUT OF CATHETER WITH HEPARINIZED SALINE, REINSERTED INTO THE MICROCATHETER, AND THE COIL WAS PUSHED INTO THE PATIENT USING A GUIDE WIRE AND ULTIMATELY DEPLOYED INSIDE THE BODY. THE PHYSICIAN COMPLETED THE PROCEDURE USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072643 ↗
• MalfunctionMar 28, 2025Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03MAR2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE. A 12MM X 30CM INTERLOCK WAS SELECTED FOR USE IN THE EMBOLIZATION OF AN INTRA-ABDOMINAL ANEURYSM IN THE SUPERIOR MESENTERIC ARTERY. DURING THE PROCEDURE, HEPARIN SALINE WAS DRIPPED CONTINUOUSLY, BUT IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED FURTHER WHEN ADVANCED TO THE TAIL END OF THE RENEGADE MICROCATHETER. AFTER SEVERAL TIMES OF WITHDRAWING AND ADVANCING THE DEVICE, THE PROBLEM STILL OCCURRED. 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 THAT THE ARM OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719610 ↗
• MalfunctionFeb 18, 2025Break; Entrapment of Device; Difficult to Insert; Material Protrusion/Extrusion; Break; Entrapment of Device; Difficult to Insert; Material Protrusion/Extrusion

  IT WAS REPORTED THAT COIL DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT INTERNAL ILIAC ARTERY. A 12MM X 30CM INTERLOCK COIL WAS SELECTED FOR EMBOLIZATION. DURING THE PROCEDURE, THE DEVICE IMMEDIATELY BECAME STIFF WHEN BEING INSERTED FROM THE INTRODUCER INTO THE MICROCATHETER. UPON REMOVAL, IT WAS NOTED THAT THE TIP OF THE COIL WAS SLIGHTLY PROTRUDING, AND THE COIL ITSELF WAS BROKEN AND FRAYED. 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 21399938 ↗
• MalfunctionJul 3, 2024Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10JUN2024. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT. THE TARGET LESION WAS LOCATED IN THE PORTAL VEIN. A 12MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT AT THE CONNECTION PART OF THE IMAGING CATHETER. 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 THAT THE ARM COIL, ZIP TAP, AND INTRODUCER SHEATH WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670557 ↗
• MalfunctionOct 12, 2023Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT THE COIL WAS BROKEN. A 12MM X 30CM INTERLOCK COIL WAS SELECTED FOR EMBOLIZATION OF GASTRIC FUNDUS VEIN. DURING THE PROCEDURE, THE 5F ANGIOGRAPHIC CATHETER WAS ACCESSED TO THE LESION POSITION VIA VEIN, AND THE COIL WAS ADVANCED TO THE EMBOLIZATION POSITION BUT COULD NOT DEPLOY DURING DELIVERY. THE COIL WAS SIMPLY PULLED OUT; HOWEVER, THE COIL WAS FOUND TO BE BROKEN WHEN IT WAS WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17925416 ↗
• MalfunctionSep 6, 2023Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17AUG2023. IT WAS REPORTED THAT THE DEVICE COULD NOT COIL UP. A 12MM X 30CM INTERLOCK WAS SELECTED FOR USE IN THE TORTUOUS SPLENIC ARTERY. DURING THE PROCEDURE, THE COIL WAS ADVANCED TO THE OUTFLOW TRACT OF THE SPLENIC ARTERY ANEURYSM HOWEVER, IT WAS NOTED THAT IT COULD NOT COIL UP. THE COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691847 ↗
• MalfunctionFeb 6, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11JAN2023. IT WAS REPORTED THAT THE COIL COULD NOT REACH THE LESION. A 12MMX30CM INTERLOCK WAS SELECTED FOR USE IN THE EMBOLIZATION OF A RENAL ANEURYSM. DURING THE PROCEDURE, A 2.4F MICROCATHETER WAS USED, AND THE FIRST COIL DEPLOYED SMOOTHLY. WHILE POSITIONING THE SECOND COIL, IT WAS FOUND THAT THE POSITION WAS NOT IDEAL, SO THE COIL WAS WITHDRAWN INTO THE PROTECTIVE SHEATH. AFTER ADJUSTING THE POSITION, IT WAS FOUND THAT THE COIL COULD NOT BE PUSHED NORMALLY IN THE MICROCATHETER. THE COIL COULD NOT REACH THE LESION. THE COIL WAS WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE 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 16306571 ↗
• MalfunctionSep 20, 2022Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT COIL PROTRUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ARTERY. A 12MM X 30CM AND 10MM X 30CM INTERLOCK COIL WAS SELECTED FOR USE ACCORDINGLY. DURING THE PROCEDURE, THE MAIN COIL AND THE ARM OF THE DELIVERY WIRE WERE SEPARATED DISTALLY FROM THE CATHETER. FLUSHING WAS PERFORMED INTERMITTENTLY PRIOR TO REMOVING THE DEVICE. SUBSEQUENTLY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459176 ↗
• MalfunctionApr 6, 2022Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18MAR2022. IT WAS REPORTED THAT THE DEVICE COULD NOT BE DETACHED. THE TARGET LESION WAS LOCATED IN THE THORACIC AORTA. A 12MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT BE DETACHED THOUGH THE INTERLOCKING ARM HAD BEEN OUT OF THE MICROCATHETER. AFTER MULTIPLE ATTEMPTS, THE SAME THING HAPPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14034937 ↗
• MalfunctionMay 19, 2021Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29APR2021. IT WAS REPORTED THAT THE COIL DID NOT FORM A BASKET SHAPE. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 12MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, THE MICROCATHETER REACHED THE TARGET POSITION. THE FIRST 14X30 COIL REACHED THE POSITION AND DEPLOYED. THE 12X30 COIL WAS THEN USED; HOWEVER, IT WAS NOTED THAT THE COIL DID NOT FORM A BASKET SHAPE AFTER IT WAS PUSHED. THE COIL WAS PUSHED AGAIN, BUT IT DID NOT FORM A BASKET SHAPE AS WELL. THE COIL WAS WITHDRAWN AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. AFTER THAT, THE PHYSICIAN USED A 10X30 AND ANOTHER 12X30 COIL AND COMPLETED THE PROCEDURE. 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 11850269 ↗
• MalfunctionMar 23, 2021Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04MAR2021. IT WAS REPORTED THAT THE COIL COULD NOT FORM A CIRCLE. THE TARGET LESION WAS LOCATED IN THE GASTRIC FUNDUS VARICOSE VEINS. A 12MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, THE COIL WAS ADVANCED FROM THE MICRO CATHETER AND COULD NOT FORM A CIRCLE. THE COIL WAS WITHDRAWN AND REDEPLOYED, HOWEVER IT WAS NOTED THAT THE COIL STILL COULD NOT FORM A CIRCLE. THE PHYSICIAN WITHDREW THEM ALL AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATION WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE TIP OF THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11559013 ↗
• MalfunctionSep 16, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT COIL PROTRUDED FROM CATHETER TIP. THE TARGET LESION AREA WAS LOCATED IN A SEVERELY TORTUOUS INFERIOR MESENTERY ARTERY. A 12MMX30CM INTERLOCK PE F-IDC EMBOLIC WAS SELECTED FOR USE IN A STENT GRAFT AND COIL EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK INSIDE THE DISTAL PART OF THE CATHETER AND PROTRUDED FROM THE TIP OF THE CATHETER UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED. THE PATIENT'S CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541774 ↗
• MalfunctionJul 27, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23 JUL 2020. IT WAS REPORTED THAT THE COIL WAS UNABLE TO CROSS THE LESION. THE HEAVY STENOSED TARGET LESION WAS LOCATED IN THE VERY CALCIFIED INTERNAL ILIAC ARTERY. A 12MM X 30CM INTERLOCK COIL WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10328402 ↗
• MalfunctionMay 18, 2020Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07MAY2020. IT WAS REPORTED THAT THE COIL WAS TWISTED AND COULD NOT BE DELIVERED INTO THE MICROCATHETER. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED BRACHIOCEPHALIC ARTERY. A 12MMX30CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DELIVERED INTO THE MICROCATHETER. THE COIL WAS TORQUED OR TWISTED DUE TO EXCESSIVE ROTATION OF THE TWIST LOCK TO UNLOCK IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10065675 ↗
• MalfunctionApr 15, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 12MMX30CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK AT THE DISTAL PART OF THE MICROCATHETER. 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 PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962296 ↗
• MalfunctionOct 18, 2019Entrapment of Device; Material Protrusion/Extrusion; Entrapment of Device; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL PROTRUSION OCCURRED. A 12MMX30CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, THE COIL BECAME STUCK IN THE DISTAL PART OF A 0.022 NON-BSC MICROCATHETER AND WAS THEN REMOVED. HOWEVER, THE COIL WAS NOTED PROTRUDING FROM THE TIP OF THE CATHETER UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9208486 ↗