Interlock™ M001361740Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729765080), received between Apr 14, 2020 and Jan 26, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30DEC2025. IT WAS REPORTED THAT THE COIL DID NOT DEPLOY. THE NON STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED VESSEL OF PROSTATE. A 2/3MM X 2.3CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK AND DID NOT DEPLOY. THE COIL 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 PUSHER WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179468 ↗
• MalfunctionFeb 24, 2022Component Missing; Material Integrity Problem; Component Missing; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS NO FIBERED COIL. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 2/3MM X 2.3CM F-IDC VORTX DIAMOND INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL FAILED TO FORM INSIDE THE LESION WHEN THE PHYSICIAN TRIED TO DEPLOY IT. THE COIL WAS WITHDRAWN AND ANOTHER ATTEMPT TO DEPLOY WAS UNSUCCESSFUL AS THE COIL STILL FAILED TO FORM. CONSEQUENTLY, IT WAS WITHDRAWN FOR THE SECOND TIME AND DEPLOYED OUTSIDE THE PATIENT, AND FOUND THERE WAS "NO FIBERED COIL". THE PHYSICIAN NOTED, "AFTER END HAS INTERLOCKING ARM THE FRONT HAS NOTHING". CONFIRMATION WAS MADE NO DEVICE FRAGMENTS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED BY UNKNOWN INJECTED EMBOLIC MICROSPHERES. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590975 ↗
• InjuryMay 4, 2021Premature Activation; Material Integrity Problem; Premature Activation; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL NEEDED TO BE SNARED TO REMOVE. A 2/3MMX2.3CM INTERLOCK WAS SELECTED FOR USE. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS VESSEL. DURING THE PROCEDURE, THE COIL WAS FED INTO THE MICROCATHETER. THE PHYSICIAN WAS NOT HAPPY WITH THE CATHETER POSITION, SO THE COIL WAS PULLED OUT WITHOUT DETACHING. THE GUIDEWIRE WAS PLACED INTO THE CATHETER TO REPOSITION, BUT THE COIL WAS UNEXPECTEDLY IN MICROCATHETER AND WAS THEN DEPLOYED IN SUBOPTIMAL POSITION. THE COIL NEEDED TO BE SNARED TO REMOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11770023 ↗
• MalfunctionApr 14, 2020Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26MAR2020. IT WAS REPORTED THAT THERE WAS NO COILING IN THE VESSEL. A 2/3MM X 2.3CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE DID NOT COIL IN THE VESSEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT'S CONDITION WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED DETACHED INTERLOCKING ARM AND MISSING COIL FIBER BUNDLES. IT WAS FURTHER REPORTED THAT THE COIL WAS NOT DEPLOYED SUCCESSFULLY AND WAS THEN RETRIEVED SAFELY. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT'S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957747 ↗