FilterWire EZ™ H749201003000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729470861), received between Nov 15, 2021 and Sep 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952861 ↗
• MalfunctionApr 11, 2026Nonstandard Device; Deformation Due to Compressive Stress; Material Integrity Problem; Mechanical Jam

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT FILETERWIRE FAILED TO DEPLOY AND DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILD CALCIFIED LEFT INTERNAL CAROTID ARTERY. A 300 CM FILTERWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, A BSC 8F GUIDING CATHETER TO THE COMMON CAROTID ARTERY BIFURCATION USING AN ANGIOGRAPHIC GUIDEWIRE AND CATHETER, WHICH WERE THEN REMOVED. A BSC THROMBUS PROTECTION SYSTEM WAS ADVANCED TO THE C3 SEGMENT OF THE INTERNAL CAROTID ARTERY; HOWEVER, IT WAS NOTED THAT DEPLOYMENT OF THE FILTERWIRE WAS DIFFICULT. AFTER MULTIPLE ATTEMPTS, THE PROXIMAL END OF THE FILTERWIRE FORMED A LOOP IN THE COMMON CAROTID ARTERY AND STILL COULD NOT BE DEPLOYED AND BECAME SEVERELY KINKED, PREVENTING FURTHER USE AND DELIVERY THROUGH AN ANGIOGRAPHIC CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SPRING TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852036 ↗
• MalfunctionDec 15, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE DIFFICULT TO RECAPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 300 CM FILTERWIRE WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE FILTERWIRE COULD NOT BE RETRACTED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803884 ↗
• MalfunctionDec 10, 2025Nonstandard Device; Difficult to Advance; Material Integrity Problem; Nonstandard Device; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20NOV2025. THE TARGET LESION WAS LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. A 300 CM FILTERWIRE EZ? WAS SELECTED FOR USE. DURING THE PROCEDURE, THE FILTERWIRE COULD NOT COME OUT DURING ADVANCEMENT. AFTER THE WHOLE FILTERWIRE WAS WITHDRAWN, THE WHOLE DELIVERY SHAFT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED SPRING TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769778 ↗
• MalfunctionSep 22, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT DEVICE REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE ORIGIN OF LEFT INTERNAL CAROTID ARTERY. A 300 CM FILTERWIRE WAS SELECTED FOR USE. THE DEVICE WAS PREPARED TO BE DELIVERED WITH A NON-BSC GUIDING CATHETER AND THE TIP OF THE DEVICE WAS PUT INTO HEPARIN WATER FOR RETRIEVAL. DURING THE RETRIEVAL, A SIGNIFICANT RESISTANCE WAS NOTED PREVENTING THE DEVICE TO BE REMOVED. AFTER APPLYING SLIGHT FORCE, THE SYSTEM WAS SUCCESSFULLY RETRIEVED HOWEVER COULD NOT BE ADVANCED AGAIN AND IT WAS FOUND THAT THE DELIVERY SHEATH WAS DAMAGED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23109714 ↗
• MalfunctionApr 10, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. THE PATIENT UNDERWENT STENT IMPLANTATION FOR CAROTID ARTERY. A 300 CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER PLACING AN 8F SHORT SHEATH, A PT2 GUIDEWIRE SUPPORT WAS USED AT THE LESION AT THE LEFT CAROTID ARTERY. HOWEVER, WHEN THE DEVICE ENTERED THE DELIVERY CATHETER, IT WAS NOTED THAT THE AVULSION PART OF THE DELIVERY SHEATH WAS FRACTURED. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084931 ↗
• MalfunctionJan 11, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT FILTER DETACHMENT OCCURRED. A 300 CM FILTERWIRE WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE FILTER SEPARATED. THE FILTER DID NOT FALL OFF AND JUST SLIDE TO THE END OF THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499382 ↗
• MalfunctionDec 11, 2023Difficult or Delayed Positioning; Difficult to Remove; Material Integrity Problem; Difficult or Delayed Positioning; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE SHEATH WAS TORN, AND TIP WAS DETACHED. A 300 CM FILTERWIRE EZ WAS SELECTED FOR USE IN THE CAROTID ARTERY. THE FILTER WAS OPERATED AS REQUIRED OUTSIDE THE BODY, AND AFTER PRIMING, IT WAS ENTERED INTO THE DELIVERY SHEATH AND DELIVERED INTO THE PATIENT'S BODY. HOWEVER, WHEN THE FILTER WAS ADVANCED, THE FILTER COULD NOT BE RELEASED, AND THE DEVICE COULD NOT BE PUSHED OR PULLED. THE PHYSICIAN USED A RETRIEVAL SHEATH UP TO THE INTERNAL CAROTID TO WITHDRAW THE FILTER, BUT IT WAS FOUND THAT THE DELIVERY SHEATH HAD BEEN TORN, AND THE PHYSICIAN DID NOT AVULSION THE DELIVERY SHEATH THROUGHOUT. AFTER FURTHER OBSERVATION, THE FILTER WAS SLIGHTLY SHAPED, AND THE TIP WAS ALREADY DAMAGED BY DETACHMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302714 ↗
• MalfunctionFeb 13, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE RECOVERY SHEATH COULD NOT BE RETRACTED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CAROTID ARTERY. A 300CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE THROMBUS PROTECTION RECOVERY SHEATH GOT DAMAGE AND COULD NOT BE RECAPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368191 ↗
• MalfunctionMay 26, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE WIRE BROKE. A 300CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING THE PREPARATION, IT WAS NOTED THAT THE WIRE BROKE WHEN TRYING TO EXPEL THE AIR FROM THE BASKET. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516535 ↗
• MalfunctionNov 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 300CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT ABOUT 10CM ON THE TIP END OF THE CATHETER WAS FRACTURED. THE CATHETER COULD NOT BE USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814697 ↗