Interlock™ M001361760Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729765103), received between Apr 8, 2020 and Jul 2, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06-JUN-2025. IT WAS REPORTED THAT COIL UNABLE TO ADVANCE AND STRETCHED OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A BSC MICROCATHETER AND 2/5MM X 5.8CM INTERLOCK WAS USED FOR TREATMENT. DURING THE PROCEDURE, THE PHYSICIAN UTILIZED A BSC MICROCATHETER TO DEPLOY THE COIL; HOWEVER, THE COIL WAS UNABLE TO BE PUSHED OUT OF THE CATHETER. FOLLOWING MULTIPLE ATTEMPTS, THE PHYSICIAN RETRACTED THE COIL, AND IT WAS NOTED THAT THE COIL HAD BECOME STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PUSHER WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22388029 ↗
• MalfunctionOct 26, 2023Contamination; Incomplete or Missing Packaging; Contamination; Incomplete or Missing Packaging

  IT WAS REPORTED THAT A DEVICE CONTAMINATION OCCURRED. A 2/5MM X 5.8CM VORTX DIAMOND PE F-IDC WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE WHEN THE PACKAGE IS UNCOVERED, THE COIL CARRIER SYSTEM WAS TAKEN OUT. HOWEVER, THE PROTECTION CABLE WAS NOT SECURING THE HOLES OF THE PROTECTION HYPOTUBE LEAVING THE COIL WITHOUT PROTECTOR AND FELL ON THE GROUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011988 ↗
• MalfunctionApr 8, 2020Break; Entrapment of Device; Stretched; Break; Entrapment of Device; Stretched

  IT WAS REPORTED THAT THE MAIN COIL WAS BROKEN. A 2/5MM X 5.8CM VORTX DIAMOND INTERLOCK COIL WAS SELECTED FOR USE. DURING A GASTROESOPHAGEAL VARICES EMBOLIZATION, AFTER 8X20 AND 6X10 COILS WERE DEPLOYED, IT WAS NOTED THAT THE 5X5.8 COIL WAS STUCK AND WAS BROKEN. WHEN THE DEVICE WAS SLOWLY PULLED, IT WAS FURTHER NOTED THAT THE COIL WAS STRETCHED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY WITHOUT ANY INTERVENTION AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9938143 ↗