ANGIOGUARD 601814RMCRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705032056748), received between Oct 12, 2020 and May 13, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (5 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.

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-1485-2023 · Root cause: Vendor change control · Recall details · FDA record ↗

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.

• MalfunctionMay 13, 2026Material Twisted/Bent

  AS REPORTED, THE FILTER ON A 6MM ANGIOGUARD EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEM MIGRATED DURING STENT INSERTION. THE FILTER WAS ABLE TO BE CAPTURED AND REMOVED FROM THE PATIENT, AND ANOTHER UNKNOWN DEVICE WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A CAROTID ARTERY STENTING (CAS) PROCEDURE. THE TARGET VESSEL WAS THE CAROTID ARTERY, WITH MILD CALCIFICATION, MILD TORTUOSITY, 80% STENOSIS, AND NO CHRONIC TOTAL OCCLUSION. IT WAS REPORTED THAT THE FILTER WAS SIZED LARGER THAN THE VESSEL AS INSTRUCTED IN THE IFU; HOWEVER, THE TARGET VESSEL DIAMETER WAS 8 MM. THE DEVICE WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THE PHYSICIAN ACHIEVED CERTIFICATION ON THE USE OF ANGIOGUARD. THERE WAS NO RESISTANCE OR FRICTION BETWEEN THE STENT DELIVERY SYSTEM AND THE ANGIOGUARD GUIDEWIRE THAT CAUSED FILTER MIGRATION DURING INSERTION, AND THERE WAS NO INDICATION THAT EITHER THE ANGIOGUARD GUIDEWIRE OR THE FILTER WAS SEPARATED. ADDITIONAL DETAILS WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED THE FI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164309 ↗
• MalfunctionDec 5, 2025Retraction Problem; Stretched; Unraveled Material; Retraction Problem; Stretched; Unraveled Material

  AS REPORTED, A 6MM ANGIOGUARD RX EMBOLIC PROTECTION DEVICE (EPD) USED IN A CAROTID ARTERY STENTING PROCEDURE COULD NOT BE RECAPTURED. THERE WAS NO REPORTED PATIENT INJURY. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE. THERE WAS NO DIFFICULTY ADVANCING THE CAPTURE SHEATH TO THE LESION. DURING RETRIEVAL, THE RETRIEVAL SHEATH WAS ADVANCED WHILE THE FILTER WIRE WAS FIXED. THE FILTER WAS DISTAL ENOUGH FROM THE LESION TO PREVENT INTERACTION WITH THE BALLOONS OR SDS USED. THERE WAS NO DEBRIS IN THE FILTER BASKET AFTER REMOVAL. THE DEVICE HAD BEEN PREPARED AND USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THERE WERE NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. THE PHYSICIAN ACHIEVED CERTIFICATION ON THE USE OF THE ANGIOGUARD RX EMBOLIC PROTECTION DEVICE AND HAD USED THE DEVICE SEVERAL TIMES PRIOR TO THIS PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727745 ↗
• MalfunctionApr 27, 2025Retraction Problem; Retraction Problem

  AS REPORTED, THE RETRIEVAL SHEATH WAS ATTEMPTED TO BE ADVANCED UNTIL THE MARKER BAND LINED UP WITH THE PROXIMAL FILTER BASKET MARKER BAND, BUT IT WOULDN¿T MAKE IT THAT FAR, AND THE PHYSICIAN WAS UNABLE TO COLLAPSE THE FILTER BASKET OF AN 7MM (FILTER BASKET) 180CM ANGIOGUARD EMBOLIC PROTECTION DEVICE INTO THE RETRIEVAL SHEATH. MULTIPLE ATTEMPTS WERE MADE, BUT EACH TIME THE DEVICE WAS RETRACTED INTO THE RETRIEVAL CATHETER, IT WOULD GET CLOSE BUT FAIL TO FULLY RETRACT. THE PHYSICIAN DID NOT BELIEVE THAT THE FILTER WAS FULL. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, AN ALTERNATIVE RETRIEVAL CATHETER FROM ANOTHER 6MM (FILTER BASKET) 180CM ANGIOGUARD DEVICE WAS UTILIZED, BUT THE FILTER STILL COULD NOT BE RECOVERED. ULTIMATELY, AFTER MULTIPLE ATTEMPTS, THE RETRIEVAL SHEATH WAS REMOVED, AND AN UNKNOWN 5F MULTI-PURPOSE (MP) GUIDE CATHETER WAS USED TO SUCCESSFULLY RETRIEVE THE DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY. UPON INSPECTION, THE FILTER WAS NOT FULL, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. ALL ITEMS WERE STORED, OPENED, AND USED PER IFU (INSTRUCTIONS FOR USE). A NON-CORDIS SHEATH WAS USED WITHOUT ISSUE. THE RIGHT INTERNAL CAROTID ARTERY WAS NOT TORTUOUS AND WAS C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916012 ↗
• MalfunctionOct 4, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE BLACK PEEL TUBING OF THE 6MM ANGIOGUARD DID NOT PEEL PROPERLY. IT WAS DIFFICULT TO PEEL. THE CASE WAS COMPLETED USING THE SAME ANGIOGUARD, ALTHOUGH ADDITIONAL TIME WAS TAKEN TO PEEL AND BACK OFF THE WIRE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS DOCTOR IS VERY PROFICIENT WITH THE DEVICE. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), AND IT WAS ALSO INSPECTED AND PREPPED ACCORDING TO THE IFU. NO UNUSUAL CONDITIONS WERE NOTED ABOUT THE DEVICE PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS FULLY SEATED IN THE FILTER BASKET INTRODUCER. THERE WAS NO DIFFICULTY ENCOUNTERED WHEN FLUSHING THE FILTER INTRODUCER AND DEPLOYMENT SHEATH. SALINE WAS NOTED TO BE WITHIN THE COIL DISPENSER AT THE GREEN DEPLOYMENT SHEATH HUB. THE TORQUE DEVICE WAS LOCKED ONTO THE GUIDEWIRE, AND THE ANTI-MIGRATION CLIP CLOSEST TO THE FILTER INTRODUCER WAS LEFT IN PLACE UNTIL AFTER THE FILTER BASKET WAS DOCKED INTO THE DEPLOYMENT SHEATH, WITH NO DIFFICULTIES DURING THE DOCKING PROCESS. THE PROXIMAL END OF THE DEPLOYMENT SHEATH WAS IN CONTACT WITH THE TORQUE NUT PRIOR TO REMOVING THE DEVICE FROM THE COIL DISPENSER. THE INTENDED PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370728 ↗
• MalfunctionOct 27, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE PEEL AWAY WAS TOUGH TO REMOVE FROM A 6MM ANGIOGUARD RX EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEM. ADDITIONALLY, THE FILTER WAS UNABLE TO BE PULLED INTO THE DEPLOYMENT SHEATH. DESPITE THE DIFFICULTIES EXPERIENCED, THE PEEL AWAY SHEATH WAS ABLE TO PEEL AWAY, AND THE FILTER WAS ABLE TO BE SUCCESSFULLY USED AND REMOVED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 90% STENOSED INTERNAL CAROTID ARTERY LESION WHICH HAD MILD CALCIFICATION AND MILD TORTUOSITY. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEPLOYMENT SHEATH TIP WAS FULLY SEATED IN THE FILTER BASKET INTRODUCER UPON OPENING THE PACKAGING. DURING FILTER RETRIEVAL, THE RETRIEVAL SHEATH WAS ADVANCED WHILE THE FILTER WIRE WAS FIXED. THE CAPTURE SHEATH ADVANCED UNTIL THE MARKER BAND LINED UP WITH THE PROXIMAL FILTER BASKET MARKER BAND. THERE WERE NO DIFFICULTIES ADVANCING THE CAPTURE SHEATH TO THE LESION. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022338 ↗
• MalfunctionOct 27, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE PEEL AWAY PART OF THE 6MM ANGIOGUARD RX WOULD NOT PEEL AWAY. IT WAS REMOVED AND A SECOND ONE WAS USED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS INSPECTED AND PREPPED PER THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THE PROXIMAL END OF THE DEPLOYMENT SHEATH WAS IN CONTACT WITH THE TORQUE NUT PRIOR TO REMOVING THE DEVICE FROM THE COIL DISPENSER. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS STILL FULLY SEATED IN THE FILTER BASKET INTRODUCER. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE FLUSHING THE FILTER INTRODUCER AND DEPLOYMENT SHEATH. SALINE WAS NOTED TO BE WITHIN THE COIL DISPENSER AT THE GREEN DEPLOYMENT SHEATH HUB. THE ANTI-MIGRATION CLIP LOCATED CLOSEST TO THE FILTER INTRODUCER WAS LEFT IN PLACE UNTIL AFTER THE FILTER BASKET WAS DOCKED INTO THE DEPLOYMENT SHEATH. THERE WAS NO DIFFICULTY NOTED WHILE DOCKING THE FILTER BASKET INTO THE DEPLOYMENT SHEATH. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18020303 ↗
• MalfunctionOct 9, 2023Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning; Detachment of Device or Device Component

  AS REPORTED, THERE WAS AN ISSUE WAS WITH THE PEELING MECHANISM OF A 6MM MEDIUM SUPPORT CAROTID ANGIOGUARD RX EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEM AS THE BLACK PEEL AWAY TUBING DID NOT PEEL PROPERLY. WHEN PEELED, THE PEEL PATTERN WAS NOT LINEAR, AND THE BLACK TUBING BROKE AWAY FROM THE WIRE. THE SEPARATED SEGMENT WAS ABLE TO BE REMOVED USING A PIN AND PULL REMOVAL; HOWEVER, THIS CAUSED THE FILTER TO MOVE. THE PROCEDURE WAS ABLE TO BE COMPLETED AND THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE TARGET VESSEL WAS THE INTERNAL CAROTID ARTERY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DIFFICULTY FLUSHING THE FILTER INTRODUCER OR DEPLOYMENT SHEATH. THERE WAS NOTHING UNUSUAL ABOUT THE DEVICE PRIOR TO USE. THE FILTER WAS ABLE TO BE REMOVED EASILY FROM THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894313 ↗
• MalfunctionOct 5, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE PEEL AWAY SHEATH OF THE ANGIOGUARD WOULD NOT COMPLETELY PEEL AWAY, IT WOULD KINK AND PULL THE BASKET BACK. THE ONLY ISSUE WITH THE DEVICE WAS THE PEEL-AWAY INTRODUCER PORTION NOT FULLY PEELING AWAY. THERE WAS NO REPORTED INJURY TO THE PATIENT. DEVICE WAS PREPPED BY THE DR AS PER IFU INSTRUCTIONS. THE DEVICE LOOKED FINE AS DID THE OTHERS THAT HAVE FAILED. PACKAGE WAS STORED PROPERLY ON A SHELF IN THE OR WITH NO DAMAGE VISIBLE TO PACKAGE. A CORDIS STENT WAS PLACED ACROSS THE CAROTID STENOSIS WITH NO PROBLEMS AFTER THE PEEL-AWAY INTRODUCER FAILED AND HAD TO BE ¿WALKED OFF THE WIRE¿. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17879707 ↗
• MalfunctionMar 28, 2022Defective Component; Defective Component

  AS REPORTED, THE ANGIOGUARD 6MM FILTER BASKET GOT STUCK WHILE ATTEMPTING TO PULL OUT. THE DEVICE WAS FLUSHED MULTIPLE TIMES, BUT BY THE TIME THEY GOT IT OUT, IT WAS RUINED. AN EXCESSIVE AMOUNT OF FORCE WAS USED WHILE TRYING. THERE WAS NO REPORTED INJURY TO THE PATIENT AS IT WAS NOT USED IN THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934091 ↗
• MalfunctionOct 21, 2021Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED, THE TIP OF 6MM MEDIUM SUPPORT ANGIOGUARD RAPID EXCHANGE (RX) EMBOLI CAPTURE GUIDEWIRE SYSTEM BECAME COILED AFTER SHAPING TO TAKE A SHARP TURN INTO INTERNAL CAROTID. THE DEVICE WAS RETURNED FOR EVALUATION AND A STRETCHED CONDITION COULD ALSO BE OBSERVED ON THE DISTAL TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12672656 ↗
• MalfunctionOct 12, 2020Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED, DURING PREP, THE 6MM BASKET, MEDIUM SUPPORT ANGIOGUARD EMBOLIC CAPTURE GUIDEWIRE SYSTEM COULD NOT BE REMOVED FROM THE TRAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ANGIOGUARD DEVICE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THE INTENDED TARGET VESSEL WAS THE CAROTID ARTERY. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION. UPON RECEIPT OF DEVICE FOR ANALYSIS, PRODUCT EVALUATION AND ANALYSIS DEMONSTRATES THE DISTAL AREA OF THE DELIVERY SHEATH PRESENTS AN ACCORDIONED CONDITION AND THE DISTAL TIP OF THE ECGW SYSTEM PRESENTS A UNRAVELED CONDITION. THE DAMAGES WERE NOTED AFTER PREP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10666645 ↗

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-1493-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
• Z-1487-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
• 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-1489-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
• Z-1484-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
• Z-1494-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
• Z-1486-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
• Z-1492-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
• Z-1490-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
• Z-1496-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
• Z-1491-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
• Z-1488-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC