Interlock™ M001361950Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729845317), received between Nov 28, 2018 and Feb 25, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Separation Failure

  IT WAS REPORTED THAT COIL FAILED TO DEPLOY REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED VESSEL IN THE DIGESTIVE TRACT. A 2D 20MM X 50CM PE F-IDC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED WITH THE ASSISTANCE OF A SNARE, AND NO DEVICE FRAGMENTS WERE FOUND IN THE BLOOD VESSEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER CONFIRMED THAT THERE WERE NO OBSERVATIONS OF PREMATURE DEPLOYMENT, COIL BREAK OR MALPOSITION OF THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442788 ↗
• MalfunctionDec 16, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED COIL WAS BROKEN INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE A 20MM X 50CM INTERLOCK COIL WAS SELECTED FOR SPLENIC ANEURYSM EMBOLIZATION. HOWEVER, IT WAS NOTED THAT THE COIL WAS BROKEN INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818519 ↗
• MalfunctionMay 29, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30APR2025. IT WAS REPORTED THAT COIL WAS UNABLE TO ADVANCE IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE LEFT PULMONARY ARTERY. A NON-BSC MICROCATHETER AND A 20MM X 50CM INTERLOCK WAS USED FOR TREATMENT. DURING THE PROCEDURE, THE COIL WAS DEPLOYED USING CONTINUOUS SALINE FLUSH. AND WAS ADVANCED THROUGH A NON-BSC MICROCATHETER. WHEN THE COIL WAS ADVANCED MIDWAY, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE CATHETER AND COULD NOT BE ADVANCED FURTHER. THE WHOLE SYSTEM WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED DETACHED MAIN COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104381 ↗
• MalfunctionDec 4, 2024Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT THE COIL WAS PROTRUDING FROM THE CATHETER'S TIP UPON REMOVAL. A 2D 20MM X 50CM INTERLOCK COIL WAS SELECTED FOR ABDOMINAL AORTIC ANEURYSM ENDOVASCULAR ISOLATION PROCEDURE. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC (BSC) MICROCATHETER WAS USED TO DELIVER THE COIL INTO THE RIGHT ILIAC ARTERY, AND THE CATHETER WAS CONTINUOUSLY FLUSHED WITH PRESSURIZED HEPARIN SALINE USING A Y VALVE. HOWEVER, THE COIL BECAME STUCK IN THE MICROCATHETER, AND HALF OF THE COIL WAS IN THE TUMOR BODY. THE COIL WAS THEN REMOVED TOGETHER WITH THE MICROCATHETER FROM THE PATIENT'S BODY; HOWEVER, IT WAS NOTED THAT THE COIL WAS PROTRUDING FROM THE CATHETER'S TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847156 ↗
• MalfunctionApr 29, 2024Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE PATIENT WAS BEING TREATED FOR ANEURYSM IN THE MODERATELY TORTUOUS HEPATIC ARTERY. A 20MM X 50CM INTERLOCK WAS SELECTED FOR USE IN THE EMBOLIZATION PROCEDURE. HOWEVER, DURING THE PROCEDURE, THE COIL WAS STUCK IN THE DELIVERY SHEATH AS THERE WAS RESISTANCE, AND THE COIL COULD NOT ADVANCE PAST THE NON-BOSTON SCIENTIFIC CATHETER HUB. IT WAS NOTED THAT THE TWIST LOCK WAS FULLY OPENED, THE INTRODUCER SHEATH WAS FIRMLY SEATED IN THE HUB OF THE CATHETER BEFORE AN ATTEMPT WAS MADE TO RETRACT THE COIL, AND CONTINUOUS FLUSHING WAS PERFORMED. THE PROCEDURE WAS POSTPONED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19208644 ↗
• MalfunctionNov 7, 2023Break; Break

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 20MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING PREPARATION, AFTER USING A MICROCATHETER, THE COIL WAS UNPACKED IN A ASEPTIC WAY, BUT WHEN TAKING THE DEVICE OUT, THERE WAS NO COIL IN THE DELIVERY SYSTEM, THE COIL HAD FRACTURED INSIDE THE INTERNAL PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18087932 ↗
• MalfunctionAug 24, 2023Break; Premature Activation; Difficult to Advance; Break; Premature Activation; Difficult to Advance

  IT WAS REPORTED THAT THE COIL WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE BRONCHIAL ARTERY. A 20MM X 50CM F-IDC 2D COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEPLOYMENT PROCESS WAS NOT SMOOTH, RESISTANCE WAS ENCOUNTERED DURING THE ADVANCEMENT AND THE DEVICE WAS DETACHED IN THE MICROCATHETER. THE DEVICE WAS NOT SENT TO THE TARGET POSITION, IT WAS PULLED OUT WITH A GUIDEWIRE AND FOUND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE COIL WAS RELEASED IN THE MICROCATHETER, AND THE FRACTURED PART WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17612535 ↗
• MalfunctionMar 10, 2022Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16FEB2022. IT WAS REPORTED THAT THE COIL FAILED TO SEPARATE. A 20MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT DETACH AND DEPLOY AFTER ENTERING INSIDE THE VESSEL. THE DEVICE WAS REMOVED AND 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 13726001 ↗
• InjuryDec 21, 2020Material Integrity Problem; Migration; Material Integrity Problem; Migration

  IT WAS REPORTED THAT A COIL MIGRATION OCCURRED. A 20MMX50CM 2D INTERLOCK COIL WAS SELECTED FOR USE ON THE RENAL ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS NOT FULLY DEPLOYED INSIDE THE PATIENT'S BODY AND WAS WASHED AWAY. IT TOOK THE PHYSICIAN TWO MORE HOURS TO REFLOAT THE COIL. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT A SNARE WAS USED TO REMOVED THE COIL. THE PHYSICIAN THOUGHT THAT THE COIL MIGRATION WAS DUE TO BLOOD FLOW VELOCITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11049506 ↗
• MalfunctionNov 28, 2018Stretched; Material Integrity Problem; Stretched; Material Integrity Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 9-NOV-2018. IT WAS REPORTED THAT THE DEVICE DID NOT COIL UP SUCCESSFULLY AND GOT ELONGATED WHEN IT WAS PULLED AND PUSHED. A STENOSED TARGET LESION WAS LOCATED AT SEVERELY TORTUOUS SPLENORENAL VEIN. A 20MM X 50CM INTERLOCK WAS SELECTED FOR USE FOR THE SHUNT EMBOLIZATION PROCEDURE . DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE DID NOT COIL UP SUCCESSFULLY AND BECAME ELONGATED WHEN IT WAS PULLED AND PUSHED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED MISSING COIL FIBER BUNDLES. DEVICE EVALUATED BY MFR: THE COIL WAS RETURNED; THE PUSHER WIRE AND THE INTRODUCER SHEATH WERE NOT RETURNED. THE VISUAL INSPECTION SHOWED THAT THE COIL WAS RETURNED STRETCHED AND KINKED. MICROSCOPIC INSPECTION OF THE MAIN COIL SHOWED THAT THE ZAP TIP HAS A SMOOTH SURFACE, THE MAIN COIL WAS STRETCHED AND KINKED, AND SOME COIL FIBER BUNDLES WERE MISSING. THE INTERLOCKING ARM WAS INSPECTED AND NO ANOMALIES WERE NOTED. THE DIMENSIONAL INSPECTION OF THE ZAP TIP OUTER DIAMETER (OD) AND THE PRIMARY COIL OD WERE WITHIN SPECIFICATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8111824 ↗