Interlock™-35 M001363640Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729793120), received between Aug 27, 2019 and Jun 13, 2023 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2023Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED, THAT A COIL PROTRUSION OCCURRED. A 15MM X 20CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED, THAT THE COIL WAS STUCK IN THE DISTAL PART OF THE CATHETER. THE COIL WIRE WAS REMOVED WITH COIL. HOWEVER, THE COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE IS NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17118153 ↗
• MalfunctionJan 10, 2022Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP WHEN REMOVED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 15MM X 20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL AND THE DELIVERY WIRE WERE PREMATURELY DETACHED IN THE CATHETER. THE COIL WAS THEN REMOVED TOGETHER WITH THE CATHETER. HOWEVER, IT WAS NOTED THAT THE COIL PROTRUDED 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 13212647 ↗
• MalfunctionAug 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23JUL2021. IT WAS REPORTED THAT THERE WAS RESISTANCE DURING COIL DELIVERY. THE TARGET LESION WAS LOCATED IN THE PORTAL VEIN. A 15MMX20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THAT THERE WAS RESISTANCE IN THE DISTAL PART OF THE CATHETER DURING COIL DELIVERY. 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 DETACHED INTERLOCKING ARM OF THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306787 ↗
• InjuryMay 6, 2021Break; Entrapment of Device; Stretched; Material Protrusion/Extrusion; Break; Entrapment of Device; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL LEFT FILAMENTS BEHIND, WAS PUSHED TO THE VESSEL AND SECURED BY FEW OTHER COILS. THE TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED LEFT OVARIAN VEIN. A 15MM X 20CM INTERLOCK COIL WAS SELECTED FOR TREATMENT. DURING DEPLOYMENT OF THE COIL, A FILAMENT WAS SEEN UNDER FLUOROSCOPY TRAILING BEHIND THE PUSHER WIRE AND THEN THE 5F NON BOSTON SCIENTIFIC CATHETER. WHEN THE CATHETER WAS PULLED BACK, IT WAS NOTED THAT THE COIL WAS UNRAVELED AND LEFT BEHIND A FILAMENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE PUSHER WIRE BUT NO COIL WAS ATTACHED. CONSEQUENTLY, THE CATHETER WAS FLUSHED BUT THE FILAMENT WAS STILL STUCK TO THE CATHETER. THE PHYSICIAN THEN USED A 0.035 NON BOSTON SCIENTIFIC HYDROPHILIC WIRE TO TRY TO DISLODGE THE COIL FROM THE CATHETER. THE COIL WAS IN PLACE AND PUSHED TO THE VESSEL. THE PHYSICIAN DECIDED NOT TO REMOVE THE COIL SINCE THE FILAMENT DID NOT EXTEND BEYOND THE OVARIAN VEIN INTO THE RENAL VEIN. THEN, A FEW OTHER INTERLOCK COILS WERE PLACED PROXIMAL TO THE FILAMENT TO SECURE IT TO THE OVARIAN VEIN AND PREVENT MIGRATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS OKAY POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788463 ↗
• MalfunctionFeb 4, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21JAN2021. IT WAS REPORTED THAT THE COIL STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 15MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER AND WAS REMOVED WITH THE CATHETER. A NEW COIL WAS SELECTED, HOWEVER, IT FAILED TO DETACH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM OF THE COIL WAS DETACHED AND FIBER BUNDLES WERE INCOMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11280561 ↗
• MalfunctionAug 27, 2019Break; Break

  IT WAS REPORTED THAT A COIL DISINTEGRATION OCCURRED. A 15MMX20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE INTERLOCK PASSED TO THE LEFT GONADAL VEIN, IT WAS NOTED THAT THE COIL DISINTEGRATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934573 ↗