Interlock™ M001361940Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729845300), received between May 13, 2019 and May 20, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 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 THE DEVICE ANALYSIS COMPLETED ON24APR2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED FORWARD. THE STENOSED TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 18MM X 50CM INTERLOCK DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE COIL PROTECTIVE SHEATH WAS INSERTED INTO THE Y VALVE, IT COULD ONLY BE RETRACTED BUT NOT ADVANCED. ATTEMPTS TO ADVANCE THE SHEATH FOLLOWING REPEATED HYDROPHILIC COATING ACTIVATION WERE UNSUCCESSFUL. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056553 ↗
• MalfunctionOct 31, 2024Failure 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 (B)(6) 2024. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE SHEATH AND COULD NOT BE ADVANCED INTO THE MICROCATHETER. AN 18MM X 50CM INTERLOCK COIL WAS SELECTED FOR EMBOLIZATION OF SPLENIC ANEURYSM. DURING THE PROCEDURE, THE STC8 MICROCATHETER WAS USED TO ADVANCE THE EMBOLIZATION SITE. THE PHYSICIAN HELD THE SYRINGE TO FLUSH THE INTERLOCK CONTINUOUSLY WITH SALINE. HOWEVER, WHEN ADVANCING THE COIL, IT WAS NOTED THAT THE COIL WAS STUCK IN THE SHEATH AND COULD NOT BE ADVANCED INTO THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578641 ↗
• MalfunctionSep 30, 2024Stretched; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT COIL STRETCH OCCURRED. THE PATIENT UNDERWENT A SPLENIC ANEURYSM EMBOLIZATION. A 18MM X 50CM INTERLOCK WAS SELECTED FOR USE. AFTER THE MICROCATHETER WAS SUPER-SELECTED INTO PLACE, THE NURSE OPENED THE COIL IN A STERILE MANNER AND CONTINUED TO ADVANCE IT WITH PRESSURIZED HEPARIN. AFTER THE 30MM COIL WAS PUSHED OUT, CONTINUED TO PUSH. DURING WITHDRAWAL, IT WAS NOTED THAT THE COIL WAS STRETCHED. 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 ARM OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20339406 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS REPORTED THAT COIL BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED INTRACRANIAL ARTERY. A 18MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT ONLY PART OF THE DEVICE COULD BE ADVANCED, AND THE OTHER HALF WAS FRACTURED. THE DEVICE WAS REMOVED FROM THE SHEATH AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651178 ↗
• MalfunctionNov 9, 2022Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED VIA MEDWATCH 3600840000-2022-8073 THAT THE COIL WAS STUCK WITH THE PUSHER WIRE. A 18MM X 50CM PE F-IDC INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK AND WOULD NOT UNLATCH FROM WIRE. THE DEVICE WAS REMOVED BY REMOVING THE MICROCATHETER AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE INVESTIGATION REVEALED MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758648 ↗
• MalfunctionAug 24, 2022Separation Failure

  EARLY 50¿S MALE WITH HISTORY OF CIRRHOSIS, PORTAL HYPERTENSION, OBESITY AND RECENT GI BLEED AND PORTAL VEIN THROMBOSIS. PROCEDURE: TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PLACEMENT, 4 X SCLEROSIS WITH EMBOLIZATION OF LARGE PORTOSYSTEMIC SHUNT AND ATTEMPTED TRANSPLENIC ACCESS TO PV SYSTEM. DURING THE PROCEDURE, THE BS INTERLOCK COIL WOULD NOT COME UNLATCHED IN THE PATIENT. IT UNLATCHED WHEN ATTEMPTING TO RE-SHEATH THE COIL. 2ND ATTEMPT- COIL WOULD NOT UNLATCH FROM WIRE. 3RD ATTEMPT- COIL CAME UNATTACHED IN THE MICROCATHETER. IN ALL SITUATIONS, THE 0.021 BERN DIREXION MICRO CATH WAS USED AS RECOMMENDED. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION, INTERLOCK¿ (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282341 ↗
• MalfunctionMar 30, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED INTERNAL ILIAC ARTERY. A 18MM X 50CM PE F-IDC INTERLOCK EMBOLICS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK INSIDE THE DISTAL PART OF A NON-BOSTON SCIENTIFIC CATHETER AND PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. ONLY THE COIL WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13953688 ↗
• MalfunctionFeb 8, 2022Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26 JANUARY 2022. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SPLENIC ARTERY. AN 18MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL BECAME STUCK AND COULD NOT ADVANCE THROUGH THE MICROCATHETER. THE DEVICE WAS REMOVED BY WITHDRAWING FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481577 ↗
• MalfunctionDec 14, 2021Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01DEC2021. IT WAS REPORTED THAT THE COIL PREMATURELY DETACHED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 18MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE COIL DETACHED EARLY FROM THE INTERLOCKING ARM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ZAP TIP AND INTERLOCKING ARM WERE DETACHED AND THE FIBER BUNDLES WERE INCOMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004804 ↗
• MalfunctionDec 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11NOV2021. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 18MM X 50CM 2D INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD BE DELIVERED EVEN AFTER MULTIPLE FLUSHING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12911529 ↗
• InjuryDec 1, 2021Break; Stretched; Material Protrusion/Extrusion; Break; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT COIL WAS FRACTURED, ELONGATED TO THE UNINTENDED SITE AND WAS SNARED. AN 18MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, ALL 17 COILS WERE DEPLOYED. HOWEVER, THE 18TH COIL WAS FRACTURED IN THREE PARTS WHILE RETRACTING POST DEPLOYMENT. FURTHERMORE, THE COIL ELONGATED ALL THE WAY FROM THE OVARIAN VEIN TO THE COMMON FEMORAL ACCESS SITE. THE FRAGMENT WAS THEN REMOVED BY UPGRADING THE SHEATH TO 6FR AND INSERTING A SNARING DEVICE TO CAPTURE THE FAULTY COIL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910857 ↗
• MalfunctionSep 28, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RENAL ARTERY. AN 18MMX50CM 2D INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME EARLY DETACHED IN THE CATHETER MIDDLE PART, WHERE THE MAIN COIL AND THE ARM OF THE DELIVERY WIRE WERE SEPARATED. THE COIL WAS PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541028 ↗
• MalfunctionAug 24, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS INTERNAL ILIAC ARTERY. A 18MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE IN AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, THE COIL COULD NOT ADVANCE ANY FURTHER THAN 20CM INTO THE BLOOD VESSEL. CONSEQUENTLY, THE DEVICE WAS PULLED OUT AND IT WAS NOTED THAT THE COIL WAS PROTRUDING FROM THE CATHETER TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12361710 ↗
• MalfunctionJun 14, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. A 18MMX50CM 2D INTERLOCK COIL WAS SELECTED FOR EMBOLIZATION OF A SPLENIC ANEURYSM. DURING THE PROCEDURE, THE COIL WAS CONNECTED AND PUSHED A THIRD OF THE COIL THROUGH THE MICROCATHETER, BUT IT COULD NOT BE PUSHED FURTHER, AND COULD NOT BE RECAPTURED. IT WAS NOTED THAT THE COIL BECAME STUCK AND PROTRUDED FROM THE CATHETER TIP WHEN REMOVED. THE COIL AND THE MICROCATHETER WERE SIMPLY PULLED OUT TOGETHER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995573 ↗
• MalfunctionNov 10, 2020Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30OCT2020. IT WAS REPORTED THAT THE COIL DETACHED PREMATURELY INSIDE THE CATHETER. THREE INTERLOCK COILS OF DIFFERENT SIZES, NAMELY, TWO 18MMX50CM AND ONE 14MMX30CM, WERE SELECTED FOR USE ON THE PULMONARY ARTERY ANEURYSM. DURING THE PROCEDURE, AFTER FRAMING WITH 5 TARGETS, THIS COIL AND ANOTHER OF THE SAME SIZE WERE INSERTED. HOWEVER, IT WAS NOTED THAT BOTH COILS DETACHED PREMATURELY INSIDE THE CATHETER. THEN, ANOTHER COIL OF UNKNOWN SIZE WAS INSERTED AND DEPLOYED SUCCESSFULLY. THEN, A 14MMX30CM INTERLOCK COIL WAS INSERTED. HOWEVER, IT WAS NOTED THAT THE COIL ALSO DETACHED PREMATURELY INSIDE THE CATHETER. THE COILS THAT DETACHED PREMATURELY WERE REMOVED WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IT WAS NOTED THAT THE COILS THAT DETACHED PREMATURELY DID NOT PROTRUDE IN THE CATHETER'S TIP DURING REMOVAL. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED AN INTERLOCKING ARM DETACHED AND MISSING COIL FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817468 ↗
• MalfunctionJan 28, 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 MILDLY TORTUOUS AND MILDLY CALCIFIED SUBCLAVIAN ARTERY. A 18MMX50CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN 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 A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9637494 ↗
• InjuryMay 13, 2019Break; Break

  IT WAS REPORTED THAT THE COIL DETACHMENT OCCURRED. AND SOME PART WAS PLACED IN THE ANEURYSM. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS HEPATIC ARTERY. A 18MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, PLACEMENT OF THE COIL BECAME DIFFICULT. IN ATTEMPTS TO RETRIEVE THE COIL WHILE INSIDE THE MICROCATHETER THE COIL BECAME UNRAVELED. THE COIL DETACHED IN ATTEMPTS TO REMOVE IT VIA A SNARE. THE MICROCATHER MOVED PROXIMALLY AND THE DETACHED COIL (10CM) WAS IMPLANTED WITHIN THE PATIENT. THE PHYSICIAN NOTED THAT THROMBOSIS FORMATION PROGRESS WHILE TRYING TO DEPLOY THE COIL BY CHANGING ITS SHAPE SEVERAL TIMES. THE PROCEDURE WAS RESCHEDULED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8604732 ↗