Interlock™-35 M001363790Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729793106), received between Sep 19, 2018 and May 16, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2023Stretched; Stretched

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL WAS DAMAGED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VEIN. A 10MM X 25CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL PART OF THE COIL GOT DAMAGED INSIDE THE CATHETER. PER PHYSICIAN'S COMMENT, IT MIGHT BE CAUSED BY A COMPATIBILITY WITH THE CATHETER, AND THE INSIDE OF THE CATHETER MIGHT HAVE BEEN DAMAGED AS MULTIPLE CATHETERS WERE USED. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERLOCK-35. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, THE DEVICE ANALYSIS REVEALED THAT THE COIL DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16941992 ↗
• MalfunctionNov 30, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM CATHETER TIP UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED INTERNAL ILIAC ARTERY. A 10MM X 25CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL STUCK IN THE DISTAL PART OF A NON-BOSTON SCIENTIFIC IMAGING CATHETER WHEN RETRACTING THE COIL IN THE CATHETER TO RECOIL IT. THE DEVICE WAS REMOVED TOGETHER WITH THE CATHETER AND WAS BEING PROTRUDED FROM THE TIP OF THE CATHETER WHEN REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890860 ↗
• MalfunctionJul 29, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04JUL2022. IT WAS REPORTED THAT THE COIL UNABLE TO ADVANCE IN CATHETER. THE TARGET LOCATION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 10MM X 25CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS UNABLE TO ADVANCE IN CATHETER AND WAS UNABLE TO WITHDRAW FROM IT. THE ENTIRE CATHETER WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129476 ↗
• MalfunctionJan 23, 2019Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10-JAN-2019. - IT WAS REPORTED THAT A COIL HAD DIFFICULTY IN THE MIDDLE OF THE ANGIOGRAPHIC CATHETER AND IT AS UNABLE TO BE PLACED DURING COIL EMBOLIZATION. A STENOSED TARGET LESION WAS LOCATED AT SEVERE TORTUOUS INTERNAL ILIAC ARTERY. A 10MM X 25CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, AT COIL EMBOLIZATION, IT WAS NOTED THAT A COIL HAD DIFFICULTY IN THE MIDDLE OF THE ANGIOGRAPHIC CATHETER AND IT AS UNABLE TO BE PLACED. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, IT WAS FURTHER REPORTED THAT THE ZAP TIP WAS DETACHED AND IT WAS NOT RETURNED, THE INTERLOCKING ARM WAS ALSO DETACHED, BUT IT WAS RETURNED INSIDE THE INTRODUCER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8271241 ↗
• MalfunctionSep 19, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-AUG-2018. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 10MM/ 25CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, AFTER BYPASS WAS COMPLETED, VIAHBAHN WAS PLACED. BLOOD FLOWED IN THE BRACHIOCEPHALIC ANEURYSM, SO COILING WAS STARTED AROUND THE VIAHBAHN AND INTO THE ANEURYSM. AFTER PLACING 3 COILS (20MM, 18MM AND 15MM INTERLOCK), THIS 10MM COIL WAS TRIED TO PLACE; HOWEVER, THE COIL BECAME STUCK IN THE DISTAL PART OF THE 0.038 NON-BSC CATHETER. THE COIL WAS THEN REMOVED FROM THE PATIENT'S BODY TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL INTERLOCKING ARM WAS DETACHED FROM THE REST OF THE COIL AND NOT RETURNED. THE DEVICE WAS RETURNED FOR ANALYSIS. THE UNIT RETURNED HAS COIL UNRAVELED, AS PART OF OVERALL VISUAL REVISION. VISUAL INSPECTION WAS PERFORMED AND OBSERVED THAT ONLY A COIL WAS RETURNED. THE COIL INTERLOCKING ARM WAS FOUND DETACHED FROM THE REST OF THE COIL, IN ADDITION IT WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889943 ↗