Interlock™-35 M001363730Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729793090), received between Oct 30, 2018 and Apr 2, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09MAR2026. IT WAS REPORTED THAT THE MAIN COIL COULD NOT BE PUSHED. A TRANSCATHETER RENAL ARTERY EMBOLIZATION PROCEDURE WAS PERFORMED. FLUSHING WAS CONDUCTED VIA INTERMITTENT HAND INJECTION PRIOR TO COIL INTRODUCTION. AFTER A CORDIS 5F C2 ANGIOGRAPHY CATHETER WAS IN PLACE, TWO INTERLOCK COILS, 10 MM X 40 CM AND 8 MM X 40 CM WERE USED FOR EMBOLIZATION, AND THEIR DEPLOYMENT WAS SMOOTH. WHEN A 6 MM X 20 CM INTERLOCK COIL WAS SELECTED, THE PHYSICIAN REPORTED THAT IT COULD NOT BE PUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT REMAINED STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766894 ↗
• MalfunctionSep 26, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03SEP2024. IT WAS REPORTED THAT THE COIL WAS DIFFICULT AND UNABLE TO PUSH OUT OF THE CATHETER AND WAS STRETCHED. THE PATIENT WAS PRESENTED WITH RENAL ANEURYSM. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 6MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS DIFFICULT AND CONSEQUENTLY UNABLE TO PUSH OUT OF THE CATHETER. WHEN PULLED OUT, IT WAS NOTED THAT THE COIL HAD BEEN STRETCHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20316086 ↗
• MalfunctionApr 9, 2024Break; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Break; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COIL BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PELVIC CAVITY. A 6MM X 20CM CUBE INTERLOCK-35 WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, IT WAS FOUND THAT THE COIL COULD NOT PUSHED OUT OF THE CATHETER. AFTER SEVERAL ATTEMPTS, THE COIL INTERLOCKING ARM WAS STRETCHED AND BECAME DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075316 ↗
• InjuryJan 11, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT COIL PROTRUSION FROM THE TARGET VESSEL AND VESSEL OCCLUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. DURING THE PROCEDURE, A 5F CATHETER SHEATH WAS INSERTED. A NON BOSTON SCIENTIFIC GUIDEWIRE WAS ENTERED INTO THE UPPER SEGMENT OF THE ABDOMINAL AORTA TOGETHER WITH A CATHETER. ANEURYSM DILATATION ON THE THE LOWER SEGMENT OF THE ABDOMINAL AORTA AND THE LEFT COMMON ARTERY WAS REVEALED BY ANGIOGRAPHY. A SINGLE CURVED ANGIOGRAPHY CATHETER ALONG WITH THE GUIDEWIRE WAS IMPLANTED ON THE LEFT INTERNAL ILIAC ARTERY. A 6MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE TO EMBOLIZE THE INTERNAL ILIAC ARTERY. HOWEVER, WHEN THE COIL WAS DEPLOYED, IT WAS NOTED THAT THE COIL WAS RELEASED FROM THE INTERLOCKING ARMS AND WAS PLACED IN AN UNINTENDED LOCATION. THE GUIDEWIRE CAME OUT DIRECTLY FROM THE DISTAL END AND THE COIL REMAINED IN THE INTERNAL CAVITY. THE DEVICE WAS REMOVED MANUALLY, AND THE TUMOR WAS TREATED WITH ANOTHER OF THE SAME DEVICE. ANGIOGRAPHY SHOWED THAT VESSEL OCCLUSION OCCURRED AND THERE WERE NO SIGNS OF CONTRAST AGENT OVERFLOW. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18497050 ↗
• MalfunctionApr 25, 2023Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05APR2023. IT WAS REPORTED THAT THE COIL PREMATURELY DETACHED. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED INTERNAL ILIAC ARTERY. A 6MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT AFTER PLACING THE FOUR INTERLOCKS, AN ATTEMPT WAS MADE TO INSERT THIS DEVICE; HOWEVER, IT STOPPED ADVANCING FROM THE MIDDLE OF THE CATHETER, AND THE COIL DETACHED WHILE PUSHING BACK. SINCE THE COIL WAS VISIBLE THROUGH THE CATHETER, ONLY THE COIL WAS REMOVE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE COIL WAS DETACHED AT THE INTERLOCKING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808098 ↗
• MalfunctionJan 28, 2022Difficult to Remove; Difficult to Remove

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05JAN2022. IT WAS REPORTED THAT THE COIL STUCK INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 6MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF THE CATHETER AND WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13389297 ↗
• MalfunctionOct 30, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-OCT-2018. IT WAS REPORTED THAT COIL COULD NOT BE INSERTED IN THE HUB OF THE CATHETER. THE MODERATELY TORTUOUS TARGET LESION WAS LOCATED IN THE LEFT INTERNAL ILIAC ARTERY (IIA). A 6MM X 20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING PREPARATION, WHEN TRYING TO INSERT THE COIL INTO THE 5F NON BSC CATHETER, IT WAS NOTED THAT THERE WAS RESISTANCE FELT AT THE HUB PART AND THE COIL COULD NOT BE INSERTED. THE DEVICE WAS REMOVED TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS POST PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED AND IT WAS NOT RETURNED AND PROXIMAL AND DISTAL FIBER BUNDLES WERE MISSING. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. A MAIN COIL WAS RETURNED FOR THIS COMPLAINT. THE DELIVERY WIRE AND INTRODUCER SHEATH WERE NOT RETURNED. THE MAIN COIL WAS FOUND KINKED AND STRETCHED; THE INTERLOCKING ARM WAS DETACHED AND IT WAS NOT RETURNED. NO MORE DAMAGES WERE FOUND IN THE RETURNED DEVICE. THE DELIVERY WIRE WAS NOT RETURNED. THE MAIN COIL ZAP TIP HAS A SMOOTH SUR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019503 ↗