ANGIOGUARD 601814RECRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032056724), received between Aug 31, 2023 and Jan 13, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (2 reports).

14 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Detachment of Device or Device Component

  AS REPORTED, PHYSICIAN AND THE TECHNICIAN WERE PREPPING A 6MM ANGIOGUARD EXTRA SUPPORT DEVICE. WHEN THEY ATTEMPTED TO BRING THE BASKET FROM THE EMBOLI CAPTURE INTO THE DEPLOYMENT SHEATH, THEY HAD A TOUGH TIME AND STRUGGLED TO GET THE BASKET INTO THE DEPLOYMENT SHEATH. THEY WERE ULTIMATELY SUCCESSFUL AND SUCCESSFULLY USED AND RETRIEVED THE DEVICE FOR THE CASE. THE PRODUCT EVALUATION OBSERVED THE FILTER BASKET AND DISTAL TIP WERE SEPARATED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. ADDITIONAL INFORMATION RELATED TO THE OBSERVED DAMAGES WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056471 ↗
• MalfunctionDec 29, 2025Defective Component; Defective Component

  AS REPORTED, THE BASKET OF A 6MM EXTRA SUPPORT ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM COULD NOT BE ADVANCED INTO THE DELIVERY SHEATH DURING PREPARATION. THE DEVICE WAS REMOVED FROM THE COIL-TUBING DISPENSER, AND THE PHYSICIAN SUBMERGED THE BASKET AND DEPLOYMENT SHEATH IN FLUSH, AFTER WHICH THE TECHNICIAN WAS ABLE TO GENTLY PULL THE BASKET INTO THE SHEATH. THE ANGIOGUARD WAS THEN SUCCESSFULLY DEPLOYED, AND THE CAROTID PROCEDURE WAS COMPLETED. AFTER REMOVAL WITH THE RETRIEVAL CATHETER, THE PHYSICIAN OBSERVED THAT ONE SIDE OF THE BASKET APPEARED DAMAGED AND MAY HAVE CAUGHT ON SOMETHING DURING WITHDRAWAL. THERE WAS NO REPORTED PATIENT INJURY. THE CASE WAS FINISHED SUCCESSFULLY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907569 ↗
• MalfunctionApr 29, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, DURING CAROTID CASE TODAY, THE PEEL AWAY SHEATH ON THE 6MM ANGIOGUARD DID NOT CORRECTLY PEEL AWAY. THE PHYSICIAN HAD TO PIN - PULL FROM ABOUT HALFWAY. THE ANGIOGUARD DEVICE WAS STILL SUCCESSFULLY PLACED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH 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 DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19208911 ↗
• MalfunctionDec 19, 2023Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED, THE SHAPABLE DISTAL TIP OF THE (ECGW) BECAME COILED UP PASSING THROUGH SHEATH. THE DISTAL TIP WAS FOUND TO BE UNRAVELED/STRETCHED DURING THE PRODUCT EVALUATION. MADE IT IMPOSSIBLE TO TRAVERSE LESION. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356754 ↗
• MalfunctionAug 31, 2023Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED, THE 6MM ANGIOGUARD PEEL AWAY DEPLOYMENT SHEATH STOPPED PEELING AWAY TOO SOON. THE ANGIOGUARD WAS PULLED OUT OF PLACE AND A SECOND ANGIOGUARD WAS OPENED AND DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. THE DEPLOYMENT SHEATH TIP WAS FULLY SEATED IN THE FILTER BASKET INTRODUCER UPON OPENING THE PACKAGE. 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 WHILE DOCKING THE FILTER BASKET INTO THE DEPLOYMENT SHEATH. THE PROXIMAL END OF THE DEPLOYMENT SHEATH WAS IN CONTACT WITH THE TORQUE NUT PRIOR TO REMOVING THE DEVICE FROM THE COIL DISPENSER. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17666909 ↗

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