FilterWire EZ™ H749390711900Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729808800), received between Feb 6, 2019 and Dec 15, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FILTER WAS DIFFICULT TO RETRACT. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A FILTERWIRE EZ? WAS SELECTED FOR LEFT HEART CATHETERIZATION WITH PERCUTANEOUS CORONARY INTERVENTION TO TREAT CORONARY ARTERY DISEASE. DURING THE PROCEDURE, THE FILTER WAS DEPLOYED. HOWEVER, IT WOULD NOT COLLAPSE AND RETRACT. THE DEVICE WAS PULLED BACK INTO GUIDE AND WAS REMOVED. 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 23810187 ↗
• MalfunctionJun 30, 2025Device-Device Incompatibility; Difficult to Advance; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT DEVICE INTERACTION OCCURRED. A 99% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. THE PHYSICIAN PLACED A EZ 2.25MM-3.5MM 190CM US CV FILTERWIRE EZ IN THE DISTAL VEIN GRAFT. THE LESION WAS DILATED WITH A BALLOON, AND A 4.0 X 20 MM SYNERGY DRUG-ELUTING STENT WAS DEPLOYED WITHOUT INCIDENT. DURING RETRIEVAL OF THE FILTERWIRE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE RETRIEVAL SHEATH COMPLETELY THROUGH THE NEWLY IMPLANTED STENT. WHILE ATTEMPTING TO RETRACT THE FILTER, IT BECAME CAUGHT ON THE DISTAL END OF THE SYNERGY STENT. UPON SUCCESSFUL REMOVAL OF THE FILTER, THE DISTAL END OF THE STENT WAS NOTED TO BE DEFORMED. A NEW GUIDEWIRE WAS USED TO RECROSS THE DAMAGED STENT, FOLLOWED BY MULTIPLE BALLOON DILATIONS. A 4.5 X 20 MM MEGATRON STENT WAS DEPLOYED WITHIN THE DEFORMED PORTION OF THE STENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. NO PATIENT HARM OR ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359549 ↗
• MalfunctionOct 15, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE BASKET PART WAS CRUNCHED WHEN DEPLOYED. A 2.25MM-3.5MM 190CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE WAS DEPLOYED, IT WAS NOTED THAT THE BASKET PART OF THE DEVICE CRUNCHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639025 ↗
• MalfunctionSep 9, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE FILTERWIRE DETACHMENT OCCURRED. A 190CM FILTERWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BASKET WAS BROKEN ON THE DEVICE. THE DEVICE NEVER WENT INSIDE THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12449043 ↗
• MalfunctionMar 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FILTERWIRE SEPARATION OCCURRED. A 2.25MM-3.5MM 190CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE FILTERWIRE WIRE BECAME SEPARATED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8441002 ↗
• InjuryFeb 6, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FILTER BASKET SEPARATED FROM THE WIRE AND WAS STENTED INSIDE THE PATIENT'S BODY. THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO DISTAL RIGHT CORONARY ARTERY. DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A 190CM FILTERWIRE EZ WAS PREPPED AND DELIVERED INTO THE TARGET LESION, TWO SYNERGY STENTS WERE DEPLOYED IN THE DISTAL AND PROXIMAL SEGMENTS OF THE SVG. SUBSEQUENTLY, THE STENT DELIVERY BALLOON SYSTEM CAME IN CONTACT WITH THE PROXIMAL COLLAR OF THE FILTERWIRE UPON POSITIONING OF THE DISTAL STENT. THE RETRIEVAL SHEATH WAS THEN INSERTED INTO THE SVG AFTER BOTH STENTS WERE PLACED; HOWEVER, AS THE SHEATH WAS BEING DELIVERED, THE GUIDE CATHETER DISENGAGED FROM THE SVG AND THE FILTER BASKET WAS WITHDRAWN, UNSHEATHED, THROUGH BOTH STENTS. CONSEQUENTLY, THE FILTER BASKET SEPARATED FROM THE FILTERWIRE AND THE REMAINING PORTION OF THE DEVICE AND SHEATH WERE THEN REMOVED FROM THE PATIENT'S BODY LEAVING THE FILTER BASKET AT THE OSTIUM OF THE SVG. SNARING WAS ATTEMPTED TO RETRIEVE THE BASKET; HOWEVER, THE BASKET WAS DRIVEN THROUGH THE PROXIMAL AND DISTAL STENTS. THE BASKET WAS THEN DELIBERATELY PUSHED BEYOND THE DISTAL STENT WHERE A THIRD STE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8313599 ↗