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ANGIOGUARD 501814RMCRecalls & reported problems

Cordis Corporation · 5mm basket, Medium Support · Class 2

All models of ANGIOGUARD (7)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
14
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705032054805), received between Mar 31, 2023 and Feb 12, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Stretched” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

13 other recalls cover devices cleared under the same FDA submission (K220654); they may or may not involve this specific model.

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 1 reportsSep 2025: 2 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Mar 24, 2023Class IOpen, Classified

    There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.

    Z-1484-2023 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Device problems

  • Stretched6
  • Unraveled Material6
  • Material Twisted/Bent4
  • Difficult or Delayed Positioning3
  • Detachment of Device or Device Component2
  • Difficult to Remove1
  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions14

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 12, 2026Stretched; Unraveled Material; Material Twisted/Bent

    AS REPORTED, THE DOCTOR TRIED TO USE A 5MM ANGIOGUARD FOR THE CAROTID ARTERY STENTING (CAS) PROCEDURE. HOWEVER, THE WIRE WAS KINKED AND COULD NOT BE USED BECAUSE IT COULD NOT CROSS THE BLOOD VESSEL. THE ANGIOGUARD ASSOCIATED WITH THE REPORTED WIRE KINKING WAS NOT USED TO COMPLETE THE PROCEDURE. THE CASE WAS COMPLETED USING A NEW ANGIOGUARD DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO ABNORMALITIES WERE NOTED PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS NOT SEATED IN THE FILTER BASKET INTRODUCER BUT WAS MANUALLY INSERTED. THE MANUAL RE-SEATING DESCRIBED ABOVE WAS NOT RELATED TO THE DOCKING STEP. NO DIFFICULTY WAS ENCOUNTERED FLUSHING THE FILTER INTRODUCER AND DEPLOYMENT SHEATH. SALINE WAS NOTED WITHIN THE COIL DISPENSER AT THE GREEN DEPLOYMENT SHEATH HUB. THE ANTI-MIGRATION CLIP CLOSEST TO THE FILTER INTRODUCER REMAINED IN PLACE UNTIL AFTER THE FILTER BASKET WAS DOCKED. DOCKING THE FILTER BASKET INTO THE DEPLOYMENT SHEATH WAS NOT DIFFICULT. NO DIFFICULTY OR ABNORMAL MANIPULATION WAS REPORTED. NO DIFFICULTY WAS ENCOUNTERED WHILE DOCKING THE FILTER B

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24329588 ↗
  • MalfunctionDec 17, 2025Stretched; Unraveled Material; Material Twisted/Bent; Stretched; Unraveled Material; Material Twisted/Bent

    AS REPORTED, THE DISTAL TIP A 5MM ANGIOGUARD EMBOLIC CAPTURE GUIDEWIRE (ECGW) WAS KINKED AND WAS UNABLE TO CROSS THE VESSEL. THE DEVICE WAS NOT USED AND THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A CAROTID ARTERY STENTING (CAS) PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED THAT THE FILTER BASKET WAS KINKED AND THE DISTAL TIP IS UNRAVELED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23831767 ↗
  • MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

    AS REPORTED, AN ISSUE OCCURRED DURING LOADING OF A 5MM ANGIOGUARD EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEM PRIOR TO THE PROCEDURE AND THE DEVICE FAILED. A NON-CORDIS EMBOLIC PROTECTION DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DAMAGE TO THE DEVICE PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS NOT FULLY SEATED IN THE FILTER BASKET INTRODUCER. ADDITIONAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED THAT THE FILTER BASKET IS KINKED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23639316 ↗
  • MalfunctionOct 21, 2025Stretched; Unraveled Material; Stretched; Unraveled Material

    AS REPORTED, THE 5MM ANGIOGUARD TIP BENT DURING THE PROCEDURE. RE-ENTRY IS NOT POSSIBLE DUE TO BENDING. THE CASE WAS COMPLETED USING AN ANGIOGUARD DEVICE THAT HAD BEEN PREPARED AS A PRECAUTION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS FULLY SEATED IN THE FILTER BASKET INTRODUCER. NO DIFFICULTY WAS ENCOUNTERED WHILE FLUSHING THE FILTER INTRODUCER AND DEPLOYMENT SHEATH, AND SALINE WAS NOTED WITHIN THE COIL DISPENSER AT THE GREEN DEPLOYMENT SHEATH HUB. THE ANTI-MIGRATION CLIP CLOSEST TO THE FILTER INTRODUCER WAS LEFT IN PLACE UNTIL AFTER THE FILTER BASKET WAS DOCKED INTO THE DEPLOYMENT SHEATH. THERE WAS NO DIFFICULTY DURING DOCKING, AND THE PROXIMAL END OF THE DEPLOYMENT SHEATH WAS IN CONTACT WITH THE TORQUE NUT PRIOR TO REMOVING THE DEVICE FROM THE COIL DISPENSER. THE LESION WAS CALCIFIED. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23348332 ↗
  • MalfunctionSep 19, 2025Stretched; Unraveled Material; Stretched; Unraveled Material

    AS REPORTED, THE PHYSICIAN WHILE PREPPING THE DEVICE COULD NOT LOAD THE FILTER OF A 5MM ANGIOGUARD RX EMBOLIC PROTECTION DEVICE. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER ANGIOGUARD WAS USED AND THE FILTER SUCCESSFULLY LOADED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN STERILE FIELD. THERE WERE NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS NOT FULLY SEATED IN THE FILTER BASKET INTRODUCER AND WAS MANUALLY INSERTED. NO DIFFICULTY WAS ENCOUNTERED WHILE FLUSHING THE FILTER INTRODUCER AND DEPLOYMENT SHEATH. THE TORQUE DEVICE WAS LOCKED ONTO THE GUIDEWIRE, AND THE CAPTURE SHEATH COIL DISPENSER WAS FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE ANTI-MIGRATION CLIP LOCATED CLOSEST TO THE FILTER INTRODUCER WAS NOT APPLICABLE IN THIS CASE. WHILE DOCKING THE FILTER BASKET INTO THE DEPLOYMENT SHEATH, SOME DIFFICULTY WAS ENCOUNTERED. IT IS NOTED THAT WHEN PROPERLY DOCKED, APPROXIMATELY HALF OF THE FILTER BASKET REMAINS VISIBLE OUT OF THE END OF THE DEPLOYMENT SHEATH. THE DEVICE WAS RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23102225 ↗
  • MalfunctionSep 5, 2025Material Twisted/Bent; Material Twisted/Bent

    AS REPORTED, A 5MM ANGIOGUARD FILTER BASKET DID NOT FULLY WITHDRAW INTO THE DEPLOYMENT SHEATH HUB, WHICH MAY HAVE SHEARED THE POROUS MEMBRANE WHEN WITHDRAWN THROUGH THE HOOP. UPON REMOVAL FROM THE HOOP, THE DEVICE TIP WAS INSPECTED AND APPEARED TO HAVE PIECES OF THE FILTER EXPOSED IN A WAY THAT INDICATED THE DEVICE WAS UNFIT FOR SAFE UTILITY. THE DEVICE WAS DISCARDED WITHOUT USE, AND A SECOND ANGIOGUARD WAS PREPPED DEPLOYED AS INTENDED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PREPPED BY THE PHYSICIAN. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22979834 ↗
  • MalfunctionAug 28, 2025Fracture; Fracture

    AS REPORTED, THREE 5MM ANGIOGUARD EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEMS FAILED TO LOAD. FOR THE FIRST ANGIOGUARD ECGW SYSTEM, INCREASED AMOUNTS OF TRACTION ON THE WIRE WERE APPLIED TO LOAD THE FILTER BASKET; HOWEVER, THE WIRE SNAPPED. THE SECOND AND THIRD ANGIOGUARD ECGW SYSTEMS BOTH HAD CRUMBLING OF THE DISTAL ENDS OF THE CATHETERS WHEN ATTEMPTING TO LOAD THE FILTERS. AN ATTEMPT TO PIN THE CATHETERS DISTALLY, NEAR TO THE RUBBER LASHING HOLDS THE DEVICE WAS MADE, BUT THE FILTERS COULD NOT BE LOADED INTO THE SHEATHS. THE USER SUGGESTED THERE WAS AN ISSUE WITH THE FILTER CHAMBERS AND THAT THE AREA WHERE THE FILTER FEEDS INTO THE CATHETER IS NOT SMOOTH ENOUGH. NONE OF THE DEVICES WERE USED IN THE PATIENT AND A NON-CORDIS EMBOLIC PROTECTION DEVICE WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICES WERE STORED PER LABELING AND WERE OPENED IN THE STERILE FIELD. THE DEVICES WERE FLUSHED THOROUGHLY TO ELIMINATE ALL BUBBLES PRIOR TO ATTEMPTING TO LOAD THE FILTERS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS UNKNOWN. THE DEVICES WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22911243 ↗
  • MalfunctionMay 18, 2025Stretched; Unraveled Material; Stretched; Unraveled Material

    AS REPORTED, NOT ALL OF THE FILTER WAS IN THE "GARAGE" AND THE TIP OF THE 5MM BASKET, MEDIUM SUPPORT, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM WAS ALREADY PRE CURVED. IT APPEARED TO PREP FINE, BUT WHEN IT WAS TAKEN OUT OF ITS LOOP, NOT ALL OF THE FILTER WAS IN THE GARAGE, AND THE TIP OF THE WIRE WAS ALREADY CURVED. THE PHYSICIAN ATTEMPTED TO RE-PREP THE FILTER. IT WOULD GO INTO THE GARAGE, BUT THE FILTER WOULD NOT COMPLETELY STAY THERE UNLESS RESISTANCE WAS APPLIED TO THE WIRE. A 4MM ANGIOGUARD FILTER WAS SUCCESSFULLY PREPPED AND USED TO COMPLETE THE CASE. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WERE NO DAMAGES FOUND ON THE DEVICE PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS RETURNED FOR EVALUATION. ADDENDUM: PER PE PRELIMINARY FINDINGS, THE DISTAL TIP IS PRESENTING A WAVED (OUT OF SHAPE) AND UNRAVELED CONDITION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22041403 ↗
  • MalfunctionJan 29, 2025Stretched; Unraveled Material; Stretched; Unraveled Material

    AS REPORTED, THE 5MM ANGIOGUARD RX WAS ABLE TO REACH THE TIGHT INTERNAL CAROTID ARTERY (ICA) LESION. THE DEVICE DID NOT PASS THROUGH THE CAROTID BIFURCATION, AS THE WIRE COULD NOT PASS THROUGH THE LESION. THE VESSEL WAS SEVERELY TORTUOUS, AND THE LESION WAS SEVERELY CALCIFIED WITH MORE THAN 80% STENOSIS. THE AORTA ANGLE WAS ACUTE, PREVENTING THE GUIDING FROM SUFFICIENTLY APPROACHING THE LESION. HOWEVER, THE LESION IS SUB-OCCLUDED, PREVENTING THE ANGIOGUARD'S TIP FROM PASSING THROUGH. WIRING ATTEMPTED, BUT THE PEEL AWAY SHEATH TWISTED AND DEPLOYED IN FRONT OF THE LESION. UNABLE TO PASS THE LESION AND TO RETRIEVE THE DEPLOYED ANGIOGUARD. ATTEMPTS WERE MADE TO LIFT THE PEEL AWAY SHEATH UPWARD, BUT RE-CAPTURE WAS UNSUCCESSFUL. THE RE-CAPTURE SHEATH WAS USED FOR REMOVAL. AS A RESULT, THE CASE WAS POSTPONED AND NOT COMPLETED. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS INSPECTED AND PREPPED AS PER THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS STILL FULLY SEATED IN THE FILTER BASKET INTRODUCER, NO MANUAL INSERTION WAS REQUIRED. NO DIFFICULTY WAS ENCOUNTERED

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21264867 ↗
  • MalfunctionNov 9, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

    AS REPORTED, AFTER THE 5MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS PLACED, THE BLACK SHEATH BROKE WHEN PEELING AWAY FROM THE WIRE. THE TEAM WAS NOT ABLE TO FULLY PEEL THE SHEATH OFF THE WIRE. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND DEVICE RETURN WAS REQUESTED; HOWEVER, NEITHER WERE NOT OBTAINED AFTER MULTIPLE ATTEMPTS MADE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20648006 ↗
  • MalfunctionOct 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED, WHEN REMOVING THE DEPLOYMENT CATHETER FOR A 5MM MEDIUM SUPPORT ANGIOGUARD RX EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEM, THE USER DID NOT WALK THE OVER THE WIRE (OTW) SECTION OF THE RX CATHETER AND THE OTW SECTION OF THE CATHETER WAS BROKEN OFF FROM THE RX SECTION OF THE CATHETER. THE FILTER WAS ABLE TO BE DEPLOYED AND USED SUCCESSFULLY DESPITE THE SEPARATION OF THE DELIVERY SHEATH. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE TARGET VESSEL WAS THE INTERNAL CAROTID ARTERY, WHICH WAS MODERATELY CALCIFIED AND SEVERELY TORTUOUS. THERE WAS NO DIFFICULTY PEELING THE DEPLOYMENT SHEATH PRIOR TO ATTEMPTING TO REMOVE THE OTW PORTION. THE FILTER WAS REMOVED BY ADVANCING AN UNKNOWN SHEATH AND CAPTURING THE FILTER WITH THE SHEATH. THE SEPARATED SEGMENT OF THE DEPLOYMENT SHEATH WAS REMOVED WITH THE UNKNOWN SHEATH. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20549915 ↗
  • MalfunctionOct 4, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

    AS REPORTED, A 5.0 MM ANGIOGUARD EMBOLIC PROTECTION DEVICE DID NOT DEPLOY. THE FILTER WOULD NOT DEPLOY FROM THE HOUSING. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE AND STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS INSPECTED AND PREPPED PER THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THE DEPLOYMENT SHEATH TIP WAS FULLY SEATED WITHIN THE FILTER BASKET INTRODUCER AFTER OPENING THE PACKAGE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20370132 ↗
  • MalfunctionJun 11, 2024Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove

    AS REPORTED, THE PEEL AWAY SHEATH ON A 5MM ANGIOGUARD RX EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEM DID NOT PEEL AWAY. ADDITIONALLY, THERE WAS DIFFICULTY REMOVING THE DEVICE, BUT IT WAS ABLE TO BE PULLED OUT AND REMAIN IN ONE PIECE. A SECOND 5MM ANGIOGUARD RX ECGW SYSTEM WAS USED; HOWEVER, THE SECOND DEVICE WAS UNABLE TO BE DEPLOYED. A THIRD 5MM ANGIOGUARD ECGW SYSTEM WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN INTERNAL CAROTID ARTERY LESION. BOTH DEVICES WERE STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE FIRST ANGIOGUARD DEVICE WAS NEVER IN AN ACUTE BEND. DURING THE USE OF THE SECOND ANGIOGUARD DEVICE, SUFFICIENT SPACE WAS ALLOWED BETWEEN THE LESION AND THE FILTER BASKET TO PREVENT INTERACTION BETWEEN DEVICES. BOTH PROXIMAL AND DISTAL MARKERS WERE POSITIONED DISTAL TO THE LESION BEING TREATED. THE DEVICE WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICES WILL BE RETURNED FOR EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19510013 ↗
  • MalfunctionMar 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    AS REPORTED, THERE WAS DIFFICULTY FLUSHING A 5MM ANGIOGUARD RX EMBOLIC CAPTURE GUIDEWIRE (ECGW). THE DEVICE WOULD NOT FLUSH TO THE END OF THE BLUE TUBE AND THE AIR COULD NOT BE REMOVED. AS A RESULT, THE DEVICE WAS DIFFICULT TO REMOVE. THERE WAS ALSO SOME DIFFICULTY DEPLOYING THE FILTER; HOWEVER, THE FILTER WAS ABLE TO BE DEPLOYED. WHEN ATTEMPTING TO CAPTURE THE FILTER, THERE WAS DIFFICULTY ADVANCING THE CAPTURE SHEATH TOWARDS THE LESION DUE TO ECGW NOT BEING ABLE TO PASS THROUGH THE RAPID EXCHANGE (RX) PORT ON THE CAPTURE SHEATH. THE CAPTURE SHEATH WAS THEN BENT AT THE AREA OF THE RX PORT IN ORDER FOR THE ECGW TO PASS THROUGH. THE CAPTURE SHEATH WAS ADVANCED WITH THE ECGW FIXED UNTIL THE DISTAL MARKER BAND MET THE PROXIMAL FILTER BASKET MARKER BAND. THE FILTER THEN COLLAPSED INTO THE CAPTURE SHEATH AS EVIDENCED BY THE REDUCTION IN FILTER BASKET DIAMETER SHOWN BY THE RADIOPAQUE STRUT MARKERS. IT WAS REPORTED THAT THE FILTER HAS SEPARATED FROM THE DELIVERY SYSTEM; HOWEVER, THE WIRE AND THE CAPTURE SHEATH WERE ABLE TO BE GRASPED AND REMOVED SIMULTANEOUSLY TO REMOVE THE FILTER. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT AN INTERNAL CAROTID ARTERY

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16659346 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K220654. One submission often covers many models, so check the product and lot details in each record.

  • Z-1496-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
  • Z-1487-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
  • Z-1492-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
  • Z-1489-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
  • Z-1493-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
  • Z-1488-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
  • Z-1485-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
  • Z-1491-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
  • Z-1486-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
  • Z-1490-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
  • Z-1495-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
  • Z-1483-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
  • Z-1494-2023 · Mar 24, 2023 · Open, Classified
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM

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