Interlock™ M001361520Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729764953), received between Apr 6, 2020 and Dec 3, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (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.

• InjuryDec 3, 2025Premature Activation; Material Protrusion/Extrusion; Premature Activation; Material Protrusion/Extrusion

  IT WAS REPORTED THAT COIL PROTRUDING OCCURRED REQUIRING INTERVENTION. A 4MM X 8CM PE F-IDC WAS SELECTED FOR USE. DURING THE PROCEDURE, A MICROCATHETER WAS USED TO DEPLOY THE COIL. HOWEVER, THE COIL WAS RELEASED PREMATURELY INSIDE THE MICROCATHETER, CAUSING THE TIP TO ENTER THE TARGET BLOOD VESSEL WHILE THE MIDDLE SECTION AND THE TAIL END WERE SUSPENDED IN THE THORACIC AORTA. AFTER MULTIPLE ATTEMPTS, THE COIL WAS UNABLE TO BE PUSHED INTO THE TARGET BLOOD VESSEL AS A WHOLE; THEREFORE, IT WAS RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709034 ↗
• MalfunctionOct 29, 2024Premature Activation; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Premature Activation; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MALPOSITION OF A DEVICE OCCURRED. A 4MM X 8CM INTERLOCK WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, HOWEVER, THE COIL WAS RELEASED WITHOUT THE RADIOLOGIST PERFORMING THE MANEUVER. THIS RESULTED IN THE COIL BEING RELEASED IN AN UNINTENDED LOCATION. NO INTERVENTIONS OR PATIENT COMPLICATIONS HAVE BEEN REPORTED DESPITE MULTIPLE INQUIRIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559843 ↗
• InjuryOct 3, 2024Premature Activation; Malposition of Device; Material Integrity Problem; Premature Activation; Malposition of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL DEPLOYED IN AN UNINTENDED TARGET LOCATION, REQUIRING SNARE FOR REMOVAL. THE TARGET LOCATION WAS LOCATED IN THE TORTUOUS CORONARY ARTERY. A 4MM X 8CM INTERLOCK COIL WAS SELECTED FOR CORONARY ARTERY FISTULA EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS SUDDENLY RELEASED IN THE CATHETER. WHEN IT WAS PULLED BACK, THE COIL WAS BROUGHT TO THE MAIN TRUNK, AFFECTING THE BLOOD FLOW OF ANOTHER VESSEL. A SNARE WAS USED TO REMOVE THE COIL, AND THE COIL WAS NOTED TO BE DEFORMED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360065 ↗
• InjuryApr 11, 2024Break; Stretched; Separation Failure; Break; Stretched; Separation Failure

  IT WAS REPORTED THAT THE COIL WAS REMOVED WITH A SNARE. THE PATIENT UNDERWENT AN AORTOPULMONARY COLLATERAL OCCLUSION. A 4MM X 8CM INTERLOCK WAS ADVANCED INTO THE 025 MICROCATHETER. HOWEVER, DURING INTRODUCTION, THE COIL BEGAN TO STRETCH OR UNFURL BUT DID NOT DEPLOY. THE COIL FAILED TO DISENGAGE, AND THE COIL LOOKED AS IF THE WIRING OF THE COIL WAS SPLITTING IN HALF. THE COIL COULD NOT BE RETRACTED BACK INTO THE MICROCATHETER AND HAD TO BE REMOVED WITH A SNARE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093224 ↗
• MalfunctionNov 8, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. A 4MM X 8CM INTERLOCK 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. ONLY THE COIL WAS REMOVED 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 15756507 ↗
• MalfunctionJul 12, 2022Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE INVESTIGATIONS COMPLETED ON 21JUN2022. IT WAS REPORTED THAT THE DEVICE DID NOT DEPLOY. A 4MM X 8CM PE F-IDC INTERLOCK EMBOLICS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE MAIN COIL WAS DETACHED AND FIBER WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991253 ↗
• MalfunctionFeb 24, 2022Break; Break

  IT WAS REPORTED THAT THE COIL WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE GASTRODUODENAL ARTERY. A 4MM X 8CM INTERLOCK COIL WAS SELECTED FOR USE. THE DEVICE WAS HYDRATED INTERMITTENTLY. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED IN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO PULL THE PUSHER BACK AND REMOVED IT COMPLETELY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT MODEL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592910 ↗
• MalfunctionJan 21, 2021Migration; Migration

  IT WAS REPORTED THAT A COIL MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON TORTUOUS INTERNAL ILIAC ARTERY. A 4MM X 8CM INTERLOCK COIL WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT COIL MIGRATION OCCURRED ABOUT 2MM. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11207814 ↗
• MalfunctionJun 15, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO SPRING IN THE DEVICE. WHEN RELEASING A 4MMX8CM INTERLOCK, THERE WAS NO SPRING NOTED ON THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10154050 ↗
• MalfunctionApr 6, 2020Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14MAR2020. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE INTRODUCER SHEATH. A 4MMX8CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT COIL GOT STUCK IN THE INTRODUCER SHEATH AND WAS NOT DELIVERED INTO THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED MISSING COIL FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928140 ↗