ANGIOGUARD 401814RMCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705032053501), received between Jun 28, 2022 and Jul 13, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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-1483-2023 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25798641 ↗
• MalfunctionAug 22, 2025Retraction Problem; Retraction Problem

  AS REPORTED, THE FILTER ON A 4MM ANGIOGUARD EMBOLIC CAPTURE GUIDEWIRE (ECGW) SYSTEM WAS UNABLE TO BE RETRIEVED, AND A NEW FILTER HAD TO BE OPENED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22871926 ↗
• MalfunctionMay 5, 2025Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED, THE PHYSICIAN TRIED TO LOAD THE ANGIOGUARD RX EMBOLI 4 MM BASKET CAPTURE GUIDEWIRE INTO THE CATHETER; HOWEVER, THE ANGIOGUARD DID NOT LOAD PROPERLY AND THE WIRE KINKED. ANOTHER ANGIOGUARD RX WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUES. THERE WAS NO REPORTED PATIENT INJURY. DURING PREPARATION, THE BASKET WOULD NOT LOAD INTO THE DELIVERY SHEATH, CAUSING THE WIRE TO KINK. THE DEVICE WAS NOT USED IN THE PATIENT. THE DIFFICULTY WAS ENCOUNTERED WHILE ATTEMPTING TO INSERT THE FILTER BASKET INTO THE DELIVERY SHEATH. THE INTENDED PROCEDURE WAS A CAROTID STENT PLACEMENT. THE DEVICE WAS HANDLED, STORED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. UPON OPENING THE PACKAGE, THE DEPLOYMENT SHEATH TIP WAS FULLY SEATED IN THE FILTER BASKET INTRODUCER AS EXPECTED. THERE WERE NO ISSUES 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 IFU. THE ANTI-MIGRATION CLIP WAS LEFT IN PLACE UNTIL AFTER THE FILTER BASKET WAS DOCKED INTO THE DEPLOYMENT SHEATH. THE CUSTOMER COULD NOT GET THE FI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960702 ↗
• MalfunctionJun 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, AFTER THE ANGIOGUARD 4MM WAS REMOVED FROM THE PATIENT, THE PHYSICIAN STATED THERE SEEM TO BE AND "EXTRA" PIECE ON THE DISTAL PORTION OF THE WIRE. THE CASE WAS COMPLETED ONCE THE FILTER WAS REMOVED, IMAGES WERE TAKEN, AND THE CASE WAS CONCLUDED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS PREPPED ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY ENCOUNTERED FLUSHING THE FILTER INTRODUCER AND DEPLOYMENT SHEATH. THE TORQUE DEVICE WAS CONFIRMED TO BE LOCKED ONTO THE GUIDEWIRE. THE ANTI-MIGRATION CLIP WAS LOCATED CLOSEST TO THE FILTER INTRODUCER AND 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 INTENDED LESION WAS IN THE INTERNAL CAROTID ARTERY (ICA). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14849148 ↗

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-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-1495-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
• Z-1487-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
• 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-1489-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
• Z-1496-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
• Z-1493-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
• 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-1484-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC