Interlock™-35 M001363540Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729793007), received between Feb 11, 2021 and Aug 12, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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

• MalfunctionAug 12, 2026Contamination; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223109 ↗
• MalfunctionMay 28, 2026Break; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE MAIN COIL ARM DETACHED DURING THE PROCEDURE. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED INTERNAL ILIAC ARTERY (IIA). A 6 MM X 10 CM INTERLOCK-35 COIL WAS SELECTED FOR USE. AFTER THE COIL WAS PLACED AT THE TARGET LESION, RESISTANCE WAS ENCOUNTERED WHILE RETRIEVING THE DELIVERY WIRE. THE WIRE WAS PUSHED AND PULLED AGAIN, AFTER WHICH THE RESISTANCE CHANGED, AND THE DELIVERY WIRE WAS REMOVED FROM THE PATIENT. INSPECTION OUTSIDE THE BODY SHOWED A FRAGMENT OF THE INTERLOCKING ARM SECTION ATTACHED TO THE TIP OF THE DELIVERY WIRE. THE DAMAGE INVOLVED THE INTERLOCKING ARM SECTION AND NOT THE COIL PORTION. IT WAS NOTED THAT THERE MAY HAVE BEEN AN ABNORMALITY IN THE SHAPE OF THE INTERLOCK ARM. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322637 ↗
• MalfunctionJun 26, 2023Device-Device Incompatibility; Physical Resistance/Sticking; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE AND PENETRATED THE NON-BOSTON SCIENTIFIC BALLOON CATHETER. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS LEFT ESOPHAGEAL VEIN. A 6MMX10CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE COIL WAS PLACED, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN RETRIEVING THE DELIVERY WIRE. THE DELIVERY WIRE PENETRATED THE BALLOON PORTION OF THE NON-BOSTON SCIENTIFIC BALLOON CATHETER, BUT DID NOT PENETRATE THE LESION. THE INTERLOCK-35 DELIVERY WIRE WAS REMOVED TOGETHER WITH THE NON-BOSTON SCIENTIFIC BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199150 ↗
• InjuryFeb 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BECAME FRACTURED AND REQUIRED SNARING. A .035 INTERLOCK 2D 6MM X 10CM EMBOLIC COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE. DURING DEPLOYMENT AND REMOVAL OF THE INTERLOCK, THE DEVICE FRACTURED. SUBSEQUENTLY, A SNARE WAS PERFORMED TO REMOVE THE DETACHED PORTION FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THERE WERE NO FIBERS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314557 ↗