ANGIOGUARD 701814RMCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705032056854), received between Aug 2, 2019 and Jul 8, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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-1486-2023 · Root cause: Vendor change control · Recall details · FDA record ↗

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.

• MalfunctionJul 8, 2026Stretched; Unraveled Material; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25751918 ↗
• MalfunctionDec 18, 2025Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED, A 7MM ANGIOGUARD EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEM COULD NOT BE PREPPED PROPERLY. DURING PREPARATION, THE FILTER WAS UNABLE TO BE PULLED INTO THE DEPLOYMENT SHEATH. THE DEVICE WAS NOT USED ON THE PATIENT AND ANOTHER 7MM ANGIOGUARD ECGW SYSTEM WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE TO THE DEVICE WAS OBSERVED PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS FULLY SEATED IN THE FILTER BASKET INTRODUCER. DURING FLUSHING, SALINE WAS NOTED WITHIN THE COIL DISPENSER AT THE GREEN DEPLOYMENT SHEATH HUB, AND THERE WAS NO DIFFICULTY FLUSHING THE DEVICE. THE TWO PROXIMAL ANTIMIGRATION CLIPS ON THE DEVICE WERE REMOVED PRIOR TO ATTEMPTING TO LOAD OR DOCK THE DEVICE, AND THE ANTIMIGRATION CLIP CLOSEST TO THE FILTER WAS LEFT IN PLACE DURING THIS PROCESS. THE DEVICE WAS NOT ALTERED AFTER DECIDING TO DISCONTINUE ITS USE, AND NO ATTEMPTS BEYOND THE ORIGINAL IFU PREPARATION WERE MADE TO PULL ON THE DISTAL TIP TO RESET THE FILTER BASKET. THE DEVICE WILL BE RETURNED FOR EVALUATION.ADDENDUM: PRODUCT EVALUATION REVEALED THAT THE DISTAL TIP WAS UNRAVELE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843708 ↗
• 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 21916007 ↗
• InjuryAug 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AFTER PREPARATION OF A 7MM MEDIUM SUPPORT ANGIOGUARD RX EMBOLIC CAPTURE GUIDEWIRE (ECGW), THE DEVICE WAS GIVEN TO THE PHYSICIAN TO SHAPE THE DISTAL TIP. AFTER SHAPING THE DISTAL TIP WITH THE BACK END OF AN 11 BLADE, THE DEVICE WAS INSERTED INTO THE PATIENT BUT WAS UNABLE TO CROSS A SEVERELY TORTUOUS CAROTID BIFURCATION LESION. THE DEVICE HAD TO PASS THROUGH ACUTE BENDS AS MULTIPLE ATTEMPTS WERE MADE TO CROSS THE SEVERE TORTUOSITY DISTAL TO THE LESION. EXCESSIVE TORQUING WAS USED DURING ADVANCEMENT OF THE DEVICE, AND EXCESS FORCE WAS PLACED ON THE FILTER TIP WHEN PREPPING, AS WELL AS TRYING TO ADVANCE THE FILTER THROUGH THE TORTUOUS LESION. THE DEVICE WAS THEN REMOVED FOR FURTHER RESHAPING OF THE DISTAL TIP WHEN THE FILTER BECAME EXPOSED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RE-CAPTURE THE FILTER WITHIN THE YELLOW AND BLACK DEPLOYMENT SHEATH, AND THEN RE-SHAPED THE DISTAL TIP ONCE AGAIN. THE DEVICE WAS THEN INSERTED INTO THE PATIENT A SECOND TIME AND WAS ABLE TO CROSS THE LESION; HOWEVER, THE DISTAL TIP OF THE DEVICE BECAME DETACHED FROM THE FILTER PORTION AND TRAVELLED DISTALLY INTO THE PRE-PETROUS PORTION OF THE INTERNAL CAROTID ARTERY. THE PHYSICIAN THEN USED A 7MM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191799 ↗
• MalfunctionMay 17, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED, AFTER PROPER PREP AND DEPLOYMENT OF A .014¿ 7MM X 160CM ANGIOGUARD RAPID EXCHANGE (RX) MEDIUM SUPPORT EMBOLI CAPTURE GUIDEWIRE SYSTEM, IT WAS DIFFICULT TO PASS THE RETRIEVAL CATHETER THROUGH THE UNKNOWN PRECISE STENT AFTER POST DILATION AND "NECK MOVEMENT". AFTER THE PHYSICIAN CAPTURED THE ANGIOGUARD AND PULLED THROUGH THE STENT, THE PROXIMAL LIP OF THE RETRIEVAL CATHETER CAUGHT AND PULLED DISTAL END OF PRECISE STENT. THIS CAUSED THE "FLOWERED" DISTAL END OF THE PRECISE STENT TO ACCORDION DOWN A BIT. THERE WAS SLIGHT FORCE REQUIRED FOR WITHDRAWAL OF THE FILTER. THE PROCEDURE WAS COMPLETED USING "NECK MANIPULATION". THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND WAS OPENED IN A STERILE FIELD. THE TARGET VESSEL WAS THE INTERNAL CAROTID AND THE LESION WAS IN A STRAIGHT SEGMENT, NOT THE BIFURCATION. THE TARGET VESSEL DIAMETER WAS 6MM. THE ANGIOGUARD WAS SIZED LARGER THAN THE VESSEL AS INSTRUCTED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICE DID NOT PASS THROUGH ANY ACUTE BENDS. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE ADVANCING/TRACKING THE DEVICE TOWARDS THE LESION. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE. THERE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831449 ↗
• MalfunctionAug 2, 2019Retraction Problem; Retraction Problem

  DURING USE, THE ANGIOGUARD WOULD NOT COLLAPSE PROPERLY FOR RETRIEVAL POST STENT AS THE FOUR DOTS WOULD NOT QUITE COLLAPSE DOWN TO ONE DOT AS WE HAD TO RETRIEVE WITH A COUPLE DOTS VISUALIZED. ALTHOUGH THE ANGIOGUARD WOULD NOT FULLY CAPTURE WITHIN THE RECAPTURE SHEATH, WE WERE ABLE TO SAFELY RETRIEVE AND REMOVE THE ANGIOGUARD WITH NO PROBLEMS OR HARM TO PATIENT. ALL PREP AND ASSEMBLY WAS DONE ACCORDING TO THE INSTRUCTION FOR USE (IFU). NOTHING UNUSUAL WAS PRACTICED. THE TARGET LESION IS THE INTERNAL CAROTID WITH NO TORTUOSITY, MODERATE CALCIFICATION AND SEVENTY PERCENT STENOSIS. THERE WAS NO DIFFICULTY ADVANCING THE CAPTURE SHEATH TO THE LESION. THE USER ADVANCE THE RETRIEVAL SHEATH OVER THE WIRE UNTIL THE USER MET THEN COLLAPSED. THE FILTER BASKET WAS DEFORMED. FORCE WAS REQUIRED FOR WITHDRAWAL OF THE FILTER PRIOR TO THE FILTER DEFORMATION. DURING THE PROCEDURE, THE FILTER WAS DISTAL ENOUGH FROM THE LESION TO PREVENT ANY INTERACTION FROM THE BALLOONS/SDS USED. THERE WAS NO INTERACTION BETWEEN THE FILTER BASKET PROXIMAL MARKERBAND AND THE DISTAL END OF OTHER DEVICES USED FOR THE PROCEDURE. THE CAPTURE SHEATH WAS ADVANCED UNTIL THE MARKER BAND LINED UP WITH THE PROXIMAL FILTER BASKET

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8857885 ↗

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-1487-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
• Z-1483-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
• Z-1491-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
• Z-1493-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
• Z-1496-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
• Z-1485-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
• Z-1494-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
• Z-1484-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
• Z-1490-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
• Z-1492-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
• Z-1488-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
• Z-1495-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
• Z-1489-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC