FilterWire EZRecalls & reported problems across all models

We found 3 models of FilterWire EZ by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 127 adverse event reports in the FDA's MAUDE database, received between Sep 26, 2018 and Sep 30, 2026 — classified as 13 injuries, 114 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (68 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FilterWire EZ problems

FilterWire EZ models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FilterWire EZ™ H749201001900

  Temporary Coronary Saphenous Vein Bypass Graft for Embolic Protection
  110 reports
• FilterWire EZ™ H749201003000

  Temporary Coronary Saphenous Vein Bypass Graft for Embolic Protection
  11 reports
• FilterWire EZ™ H749390711900

  Temporary Coronary Saphenous Vein Bypass Graft for Embolic Protection
  6 reports

Recent FilterWire EZ adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryAug 14, 2026Difficult to Remove; Deformation Due to Compressive Stress; Material Integrity Problem; Mechanical Jam

  It was reported that removal difficulty occurred. The 70% stenosed target lesion was located in the mildly calcified and mildly tortuous carotid artery. A 190 cm FilterWire was prepared outside the patient. The filter was deployed and recaptured into the delivery sheath in a saline bath without issue. A long sheath was positioned and the FilterWire was then advanced in the patient to the target location. During deployment, significant resistance was encountered, and the filter could not be completely deployed. The physician attempted to recapture the filter, but retrieval was difficult. The FilterWire was withdrawn using the long sheath, and the pushing guidewire was found to be kinked and deformed. The procedure was completed with a non-BSC device. The patient remained stable following the procedure, and no patient complications were reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254227 ↗
• InjuryJul 21, 2026Difficult to Remove

  IT WAS REPORTED THAT FILTER WAS DIFFICULT TO RECAPTURE REQUIRING ADDITIONAL INTERVENTION. A 190 CM FILTER WIRE EZ WAS SELECTED FOR USE IN A CAROTID ARTERY. DURING THE PROCEDURE, IT WAS DIFFICULT TO WITHDRAW THE FILTER WIRE, AND IT WAS DIFFICULT TO PUT IT INTO THE RECOVERY SHEATH. THE RESISTANCE WAS OBVIOUS, SO THE FILTER WIRE WAS PUT INTO THE RECOVERY SHEATH WITH THE COOPERATION OF THE NON- BOSTON SCIENTIFIC MIDDLE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892739 ↗
• MalfunctionJul 7, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT FILTERWIRE RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 190 CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING PREPARATION, THE PACKAGE WAS UNPACKED AND IT WAS NOTED THAT THE BOTTOM OF THE FILTERWIRE WAS RUPTURED. 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 25738412 ↗
• MalfunctionJun 23, 2026Difficult or Delayed Activation; Material Integrity Problem

  IT WAS REPORTED THAT THE FILTERWIRE WAS FRACTURED. DURING A CAROTID ARTERY STENTING PROCEDURE, AN 8FR X 90 CM SHEATH WAS USED TO DELIVER A 190 CM FILTERWIRE EZ; HOWEVER, THE DEVICE COULD NOT BE DEPLOYED. FOLLOWING RECAPTURE, FRACTURE OF THE FILTERWIRE GUIDEWIRE WAS IDENTIFIED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595466 ↗
• MalfunctionMay 21, 2026Difficult to Remove

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT WITH STENOSIS AT THE INITIAL SEGMENT OF THE INTERNAL CAROTID ARTERY UNDERWENT PERCUTANEOUS CAROTID ARTERY STENT IMPLANTATION UNDER ANGIOGRAPHIC GUIDANCE WITH A 190 CM FILTERWIRE PLACED ACROSS THE LESION. THE TARGET LESION SHOWED 80% STENOSIS IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED CAROTID ARTERY. A 10.0-31 CAROTID WALLSTENT WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE STENT COULD NOT BE RELEASED OR WITHDRAWN NORMALLY. THE STENT AND DELIVERY SYSTEM BECAME STUCK TOGETHER AND WERE REMOVED TOGETHER WITH THE FILTERWIRE THROUGH AN UNKNOWN 8F GUIDING CATHETER POSITIONED HIGH IN THE VESSEL. THE DEVICE WAS EXCHANGED, AND ANOTHER FILTERWIRE AND A 7 X 40 CAROTID ARTERY STENT WERE USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL MANEUVERS WERE REQUIRED. NO CHALLENGING ANATOMY, OR OTHER PROCEDURAL FACTORS WERE REPORTED TO HAVE CONTRIBUTED TO THE EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246690 ↗
• MalfunctionMay 19, 2026Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY OCCURRED DURING RETRIEVAL OF THE FILTERWIRE. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 190 CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE FILTERWIRE BODY COULD NOT BE RETRACTED. 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 25221798 ↗
• 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 ↗
• MalfunctionMar 31, 2026Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT DEVICE DIFFICULT REMOVE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY (STENOSIS OF C1 SEGMENT OF RIGHT INTERNAL CAROTID ARTERY). A 190 CM FILTERWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN NOTED SIGNIFICANT RESISTANCE WHILE RETRACTING THE FILTERWIRE. THE FILTERWIRE WAS THEN SMOOTHLY INSERTED INTO THE BODY ALONG THE LONG SHEATH AND ADVANCED TO THE LESION SITE. THE FILTERWIRE WAS SLOWLY DELIVERED TO THE DISTAL END OF THE C2 SEGMENT TO PREPARE FOR DEPLOYMENT, HOWEVER, IT WAS FOUND THAT THE FILTERWIRE BODY COULD NOT EXPAND ALL THE TIME, AND REPEATED ATTEMPTS FAILED. THE DELIVERY SHEATH WAS SUBSEQUENTLY WITHDRAWN FROM THE BODY, AND THE DELIVERY GUIDEWIRE WAS ADVANCED EXTERNALLY. AFTER REPEATED ADVANCING OF THE DELIVERY GUIDE WIRE, THE FILTERWIRE BODY WAS FINALLY PUSHED OUT AND THE PHYSICIAN USE THE RECOVERY SHEATH TO DEPLOY THE FILTERWIRE. THE FILTERWIRE WAS INSERTED INTO THE RECOVERY SHEATH, WHICH WAS ADVANCED TO THE Y-VALVE FOR DELIVERY. ALTHOUGH THE DEVICE WAS POSITIONED, THE FILTERWIRE BODY STILL DID NOT EXPAND, AND THE RECOVERY SHEATH COULD NOT BE WITHDRAWN. THE RECOVERY SHEATH AND FILTERWIRE WERE REMOVED TOGETHER FROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747627 ↗
• MalfunctionMar 23, 2026Material Integrity Problem

  IT WAS REPORTED THAT DELIVERY SHEATH WAS TORN. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 190 CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING NORMAL FLUSHING ANG UPON RECOVERY OF THE FILTERWIRE INTO THE DELIVERY SHEATH, IT WAS NOTED THAT THE DELIVERY SHEATH WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE IMPLANTED SHEATH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670565 ↗
• MalfunctionMar 12, 2026Nonstandard Device; Failure to Advance; Material Integrity Problem; Mechanical Jam

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16FEB2026. IT WAS REPORTED THAT FILTERWIRE COULD NOT BE DEPLOYED AND WAS DEFORMED. THE MORE THAN 90% STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 190 CM FILTERWIRE EZ WAS SELECTED FOR USE IN A CAROTID ARTERY STENTING. DURING THE PROCEDURE, THE FILTERIWRE ATTEMPTED TO CROSS THE CHALLENGING LESION BUT FAILED. CONSEQUENTLY, WHEN ATTEMPTED TO DEPLOY MULTIPLE TIMES, IT COULD NOT BE DEPLOYED. THE FILTERWIRE WAS WITHDRAWN AND IT WAS NOTED THAT IT WAS DEFORMED. THE FILTERWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED SPRING TIP DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24583570 ↗
• MalfunctionFeb 23, 2026Difficult to Remove; Mechanical Jam

  IT WAS REPORTED THAT DEVICE DIFFICULT TO REMOVE OCCURRED. THE TARGET LESION WAS LOCATED IN THE C1 SEGMENT OF RIGHT INTERNAL CAROTID ARTERY. A 190 CM FILTERWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, DURING THE PROCEDURE, THE FILTER WIRE WAS REMOVED AND PLACED INTO THE DELIVERY SHEATH WHILE SUBMERGED IN A SALINE BASIN, THE PHYSICIAN NOTICED SIGNIFICANT RESISTANCE WHEN HANDLING THE FILTER WIRE. THE SYSTEM WAS THEN ADVANCED THROUGH THE LONG SHEATH TO THE TARGET LESION, AND THE FILTER WIRE WAS SLOWLY DELIVERED TO THE DISTAL END OF THE C2 SEGMENT IN PREPARATION FOR DEPLOYMENT. THE PHYSICIAN USED THE MATCHING TWIST CONTROLLER TO ENTER THE DELIVERY GUIDEWIRE, SECURED IT AT THE Y-VALVE OF THE LONG SHEATH, AND THEN SLOWLY PULL BACK THE DELIVERY SHEATH. HOWEVER, IT WAS OBSERVED THAT THE FILTER WIRE FAILED TO OPEN DESPITE MULTIPLE ATTEMPTS. THEN THE DELIVERY SHEATH WAS WITHDRAWN TO THE OUTSIDE OF THE BODY, AND THE DELIVERY GUIDEWIRE WAS PUSHED OUTSIDE THE BODY. AFTER REPEATED ATTEMPTS, THE FILTER WIRE WAS FINALLY PUSHED OUT, AND THE PHYSICIAN DECIDED TO USE THE RECOVERY SHEATH TO RELEASE THE FILTER WIRE. AFTER THE FILTERWIRE WAS RELEASED, IT WAS FOUND THAT THE RECOVERY SHEATH COULD NOT B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416519 ↗
• MalfunctionFeb 13, 2026Mechanical Problem; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16JAN2026. IT WAS REPORTED THAT THE WIRE WAS EXPOSED THROUGH THE SHEATH SLIT. A 190 CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING PREPARATION, UPON FLUSHING, IT WAS FOUND OUT THAT THE WIRE WAS EXPOSED THROUGH THE SHEATH SLIT. 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 FILTER BAG DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332298 ↗
• MalfunctionFeb 6, 2026Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE FILTERWIRE IS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 190 CM FILTERWIRE EZ? WAS SELECTED FOR USE. DURING THE PROCEDURE, THE FILTER WIRE COULD NOT BE RETRACTED. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278330 ↗
• MalfunctionFeb 4, 2026Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE FILTERWIRE COULD NOT BE RETRACTED. THE TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY STENOSIS. A 190 CM FILTERWIRE EZ WAS SELECTED FOR USE FOR THIS STENTING PROCEDURE. DURING THE PROCEDURE, THE FILTERWIRE COULD NOT BE RETRACTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262101 ↗

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