EZ Bent Tip H749501001500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729479109), received between Jan 28, 2020 and Sep 26, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2022Difficult to Remove; Defective Device; Difficult to Remove; Defective Device

  IT WAS REPORTED THAT THE FILTERWIRE WAS CAUGHT IN THE NON-BSC STENT AND COULD NOT BE PULLED UP. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY AND COMMON CAROTID ARTERY. A FILTERWIRE EZ WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER POST DILATION, WHEN THE FILTERWIRE EZ RETRIEVAL SHEATH WAS REMOVED IT GOT CAUGHT IN A NON-BSC STENT AND COULD NOT BE PULLED UP. ANOTHER FILTERWIRE EZ WAS SELECTED, HOWEVER, RESISTANCE WAS FELT MIDWAY, AND IT COULD NOT BE ADVANCED. THE BENT TIP WAS RETRIEVED ONCE AND NOTED A WEAKENING OF THE TIP. EVENTUALLY, AN EXTENSION WIRE WAS ATTACHED TO FILTERWIRE EZ, THEN A NON-BSC CATHETER WAS ADVANCED, AND IT WAS ABLE TO RETRIEVE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15489229 ↗
• InjuryJan 28, 2020Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT A FRAGMENT OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A EZ BENT TIP FILTERWIRE WAS SELECTED FOR USE. DURING PROCEDURE, THE FILTERWIRE WAS DEPLOYED IN THE DISTAL LESION. PRE-DILATATION AND STENT PLACEMENT WERE COMPLETED. ANGIOGRAPHY WAS PERFORMED AND APPOSITION TO VESSEL WALL WAS CONFIRMED. WHEN THE FILTERWIRE WAS TRIED TO RETRIEVE USING THE RETRIEVAL SHEATH, IT BECAME CAUGHT INSIDE THE STENT, AND IT WAS UNABLE TO RETRIEVE. THE BENT TIP DEVICE WAS REMOVED AND RETRIEVAL WAS TRIED TO PERFORM, HOWEVER, IT STILL CAUGHT AT THE SAME LOCATION, AND IT WAS UNABLE TO RETRIEVE. DOCK REPLACEMENT WAS DONE AND RETRIEVAL WAS PERFORMED USING THE BENT TIP DEVICE, BUT STILL CAUGHT AT THE SAME LOCATION. REPETITIVE PUSH AND PULL WERE DONE, EVENTUALLY THE FILTERWIRE DROPPED SLIGHTLY, HOWEVER THE LOOP REMAINED OPEN. AFTER THAT, APPROACH WAS TRIED TO PERFORM USING BENT TIP, BUT THE MARKER OF THE BENT TIP DEVICE SLIPPED THROUGH THE FILTERWIRE, AND IT REACHED UP TO M1. THE FILTERWIRE WAS REMOVED FORCIBLY WHILE BEING DEPLOYED, AND THE PROTRUDING TIP WAS RETRIEVED. STENT RETRIEVER, SNARE, AND ASPIRATION CATHETER WERE FUL

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9636533 ↗