ANGIOGUARD 501814RECRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705032054782), received between Feb 15, 2021 and Mar 16, 2026 — classified as 2 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-1489-2023 · 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 16, 2026Defective Component; Detachment of Device or Device Component

  AS REPORTED, THE 5MM ANGIOGUARD WAS INSERTED AND SUCCESSFULLY DEPLOYED. UPON REMOVING THE DEVICE AT THE END OF THE PROCEDURE, PHYSICIAN NOTICED THAT THE BASKET HAD BECOME DAMAGED. HE BELIEVED THIS WAS DUE TO THE HEAVY CIRCUMFERENTIAL CALCIUM IN THE ICA. HE TOOK A PICTURE OF THE ICA TO ENSURE THAT NOTHING EMBOLIZED, WHICH IT HAD NOT, AND THE CASE WAS FINISHED SUCCESSFULLY. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS OPENED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: THE FILTER BASKET WAS RECEIVED SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607455 ↗
• MalfunctionFeb 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, AFTER FLUSHING THE 5MM 180CM ANGIOGUARD RAPID EXCHANGE (RX) EXTRA SUPPORT EMBOLI CAPTURE GUIDEWIRE SYSTEM WITH HEPARIN SALINE BEFORE IMPLANTATION TO PREPARE THE UNKNOWN SHEATH, BUT IT COULD NOT BE NORMALLY RECOVERED THE UNKNOWN SHEATH. THE OPERATOR CAREFULLY OBSERVED THAT THE HEAD-END OF THE OMENTUM OF THE ANGIOGUARD HAD FALLEN OFF, SO THE RELEASED SHEATH WAS FAILED TO RECOVER. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER ANGIOGUARD TO COMPLETE THE OPERATION. THERE WAS NO REPORTED PATIENT INJURY. A CAROTID UNKNOWN STENT IMPLANTATION WAS PERFORMED IN A PATIENT WITH RIGHT CAROTID STENOSIS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11329786 ↗

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-1486-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
• Z-1483-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
• 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-1488-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
• 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-1495-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
• 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-1487-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
• Z-1496-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE