FilterWire EZ™ H749201001900Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 08714729470854), received between Sep 26, 2018 and Aug 14, 2026 — classified as 12 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (57 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 25 most recent of 110 reports, in the reporter's own words as published by the FDA.

• 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 The FilterWire was withdrawn using the long sheath, and the pushing guidewire was found to be kinked and deformed.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 ↗
• 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 ↗
• MalfunctionJan 13, 2026Difficult to Open or Remove Packaging Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE OPENING OF THE CAROTID ARTERY. A 190 CM FILTERWIRE EZ WAS SELECTED FOR USE. HOWEVER, WHEN THE PACKAGE WAS OPENED FOR PREPARATION, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 24052628 ↗
• MalfunctionJan 9, 2026Nonstandard Device

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 190 CM FILTERWIRE WAS SELECTED FOR USE IN AN INTERNAL CAROTID ARTERY STENTING. AFTER UNPACKING THE DEVICE, IT WAS FOUND THAT THE FRONT END OF THE GUIDEWIRE WAS BROKEN. 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 24028410 ↗
• MalfunctionDec 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT FILTERWIRE FRACTURE OCCURRED, A 190 CM FILTERWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE FILTERWIRE FRACTURED INSIDE THE VESSEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23868067 ↗
• MalfunctionDec 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE AND THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE SEVERELY STENOSED C1 SEGMENT OF THE RIGHT CAROTID ARTERY. A 190 CM FILTERWIRE EZ? WAS SELECTED FOR USE. DURING THE PROCEDURE, THE FILTERWIRE WAS POSITIONED AND DEPLOYED. HOWEVER, THE RETRIEVAL SHEATH COULD NOT BE RETRIEVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RETRIEVAL SHEATH WAS PULLED OUT OF THE PATIENT TOGETHER WITH THE FILTER WIRE. THE PATIENT WAS SEDATED AND UNDER LOCAL ANESTHESIA WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839114 ↗
• MalfunctionDec 16, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE DEVICE FAILED TO PEEL-AWAY. THE STENOSED TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 190 CM FILTERWIRE EZ WAS SELECTED FOR USE. HOWEVER, AFTER THE DEVICE WAS USED TO CROSS THE CALCIFIED LESION, RESISTANCE WAS ENCOUNTERED WHEN THE DELIVERY SHEATH WAS PULLED BACK DURING DEPLOYMENT. THE GUIDEWIRE TORQUE CONTROLLER WAS PUSHED TO THE HEMOSTATIC VALVE, AND THE DELIVERY SHEATH CONTINUES TO BE PULLED BACK, BUT STILL COULD NOT BE MOVED. THE FILTERWIRE COULD NOT BE DEPLOYED. THE ENTIRE SYSTEM WAS WITHDRAWN AND 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 23820992 ↗
• MalfunctionDec 4, 2025Failure to Advance; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06NOV2025 IT WAS REPORTED THAT DEVICE KINKED AND DIFFICULT TO CROSS LESION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 190 CM FILTERWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE GUIDING WIRE OF THE FILTERWIRE TRIED TO CROSS THE TARGET LESION, A RESISTANCE WAS NOTED. AFTER WITHDRAWING THE GUIDING WIRE, IT WAS FOUND THAT THE TIP OF THE GUIDING WIRE WAS BENT AND DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SPRING TIP DETACHED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720234 ↗
• MalfunctionDec 3, 2025Nonstandard Device; Mechanical Jam; Nonstandard Device; Mechanical Jam

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06NOV2025. IT WAS REPORTED THAT THE FILTERWIRE FAILED TO DEPLOY. A PATIENT UNDERWENT A LEFT-SIDED PERCUTANEOUS CAROTID ARTERY BALLOON DILATION AND STENTING PROCEDURE, WHICH INCLUDED STENT IMPLANTATION UNDER A CEREBRAL FILTERWIRE AND FULL CEREBRAL ANGIOGRAPHY. THE TARGET LESION, WITH MORE THAN 70% STENOSIS, WAS LOCATED AT THE C1 OPENING OF THE LEFT INTERNAL CAROTID ARTERY. A 190CM FILTERWIRE WAS ADVANCED INTO THE TARGET LESION FOR INTERNAL CAROTID ARTERY STENTING. WHEN REACHING C2 SEGMENT OF LEFT INTERNAL CAROTID ARTERY, UPON DEPLOYMENT, IT WAS NOTED THAT THE FILTERWIRE COULD NOT BE DEPLOYED DESPITE MULTIPLE ATTEMPTS. THE PHYSICIAN WITHDREW THE PROTECTION SYSTEM ALONG THE VESSEL AND ATTEMPTED TO DEPLOY IT IN AN EXTRACORPOREAL ENVIRONMENT, BUT HIGH RESISTANCE PERSISTED, AND THE GUIDEWIRE BECAME DEFORMED. ALTHOUGH THE FILTERWIRE WAS EVENTUALLY PUSHED OUT, IT COULD NOT FULLY EXPAND AND WAS DEEMED UNUSABLE FOR THROMBUS CAPTURE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. HOWEVER, DEVICE ANALYSIS REVEALED THE SPRING TIP AND ALL SECTION OF THE FILTER INCLUDING THE NOSECONE WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708883 ↗
• MalfunctionNov 20, 2025Nonstandard Device; Material Integrity Problem; Mechanical Jam; Nonstandard Device; Material Integrity Problem; Mechanical Jam

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24OCT2025. IT WAS REPORTED THAT THE FILTER WIRE FAILED TO DEPLOY AND DAMAGED OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 190 CM FILTER WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE FILTER WIRE COULD NOT BE DEPLOYED, AND DAMAGE WAS NOTED AT ONE-THIRD OF ITS LENGTH IN THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DELIVERY SHEATH DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606841 ↗
• MalfunctionNov 3, 2025Difficult or Delayed Positioning; Mechanical Problem; Nonstandard Device; Material Integrity Problem; Mechanical Jam; Difficult or Delayed Positioning; Mechanical Problem; Nonstandard Device; Material Integrity Problem; Mechanical Jam

  IT WAS REPORTED THAT HANDLE FRACTURED OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 190 CM FILTERWIRE EZ? WAS SELECTED FOR USE. DURING PREPARATION TO DEPLOY THE FILTERWIRE, THE HANDLE FRACTURED, PREVENTING THE FILTERWIRE FROM OPENING. THE DEVICE WAS REMOVED, THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THERE WAS NO INTERVENTION HAPPENED WHEN THE ISSUE HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457118 ↗
• MalfunctionOct 15, 2025Nonstandard Device; Material Integrity Problem; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT THE FILTERWIRE SNAPPED AND FRACTURED. A 190 CM FILTERWIRE EZ WAS SELECTED FOR LEFT HEART CATHETERIZATION. DURING THE PROCEDURE, THE FILTERWIRE SNAPPED AND FRACTURED ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FILTERWIRE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292563 ↗
• MalfunctionSep 25, 2025Nonstandard Device; Difficult to Remove; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 190 CM FILTERWIRE EZ WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE STENT WAS RELEASED, THE FILTERWIRE AND DELIVERY SYSTEM HAD RESISTANCE. THE DELIVERY SYSTEM COULD NOT BE WITHDRAWN ALONG THE FILTERWIRE, AND COULD ONLY BE WITHDRAWN TOGETHER. 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 23147764 ↗
• MalfunctionSep 5, 2025Nonstandard Device; Difficult to Remove; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE OVER 85% STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A 190 CM FILTERWIRE EZ? WAS SELECTED FOR USE. HOWEVER, DURING THE RETRIEVAL OF THE DEVICE, THE RETRIEVAL WAS DIFFICULT AND STICKY, AND IT COULD NOT BE RETRACTED INTO THE SHEATH. THE PHYSICIAN REPEATEDLY TRIED TO PULL THE FILTER GUIDEWIRE FORCEFULLY TO RETRIEVE IT BACK INTO THE SHEATH. THE FILTERWIRE EZ? WAS ULTIMATELY EXCHANGED, AND THE DEVICE WAS POSITIONED 2 CM DISTAL TO THE LESION. A 4.0 X 30 MM BALLOON CATHETER WAS ADVANCED OVER THE FILTERWIRE EZ? AND INFLATED FOR DILATION. POST-DILATION ANGIOGRAPHY WAS PERFORMED, AND THE BALLOON WAS WITHDRAWN. SUBSEQUENTLY, A 7.0 X 40 MM WALLSTENT WAS DEPLOYED OVER THE FILTERWIRE EZ?. ANGIOGRAPHY CONFIRMED SUCCESSFUL STENT DEPLOYMENT WITH OPTIMAL POSITIONING, AND THE PROCEDURE WAS COMPLETED. 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 22978402 ↗