ANGIOGUARD 801814RMCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032056946), received between May 26, 2017 and Mar 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Increase in Suction” (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-1487-2023 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Stretched; Increase in Suction

  AS REPORTED, WITH ALL MIGRATION CLIPS REMOVED ON THE 8MM ANGIOGUARD, THE DEVICE WAS HAVING ISSUES BEING REMOVED FROM THE HOOP. A DIFFERENT DEVICE HAD TO BE OPENED AND USED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS OPENED AND PREPPED PER INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPER PER THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN HAD EXTREME DIFFICULTY REMOVING THE DEVICE. A NEW ANGIOGUARD DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDENDUM: THE PE RESULTS PRESENTED THE DISTAL TIP (ECGW)-UNRAVELED/STRETCHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674972 ↗
• MalfunctionMay 26, 2017Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE ANGIOGUARD FILTER WAS DEPLOYED IN A NORMAL FASHION, HOWEVER, DURING THE RETRIEVAL PORTION, THE PHYSICIAN COULD NOT GET THE FILTER TO COLLAPSE INTO RETRIEVAL SHEATH. THE FILTER WAS REMOVED WHILE BEING PARTIALLY COLLAPSE AS IT WOULD NOT COLLAPSE COMPLETELY.  AT THE TIME OF THE PROCEDURE, THERE WERE NO SIGNS OF AN ADVERSE EVENT OR COMPLICATIONS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6593932 ↗

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-1495-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
• Z-1490-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
• Z-1484-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
• Z-1492-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
• Z-1496-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
• Z-1486-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
• 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-1488-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
• Z-1483-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
• 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-1491-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE