ANGIOGUARD 603014MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032056793), received between Jan 5, 2023 and Jan 5, 2023 — classified as 1 injury.

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-1488-2023 · Root cause: Vendor change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AS REPORTED, THE RECAPTURE SYSTEM CATHETER TIP AND DISTAL MARKER BAND OF A 6MM ANGIOGUARD EMBOLIC PROTECTION DEVICE GOT HUNG UP ON AN UNKNOWN PRECISE STENT AND WHEN THE PHYSICIAN WITHDREW THE FILTER AND CATHETER BACK IT WAS DISCOVERED THAT THE TIP OF THE CATHETER AND DISTAL MARKER BAND WAS DETACHED AND REMAINED ON THE WIRE IN THE BODY. AFTER DEPLOYING AN UNKNOWN PRECISE STENT IN THE CAROTID, THE PHYSICIAN INSERTED THE FILTER RECAPTURING CATHETER AND ADVANCED IT UP TO THE FILTER THEN HE WITHDREW THE FILTER INTO THE CATHETER THUS CAPTURING IT. THE PHYSICIAN SLOWLY PULLED THE FILTER & CATHETER BACK THROUGH THE STENT WHEN IT GOT HUNG UP ON THE STENT. THE PHYSICIAN ADVANCED THE FILTER BACK UP INTO THE INTERNAL CAROTID AND REDEPLOYED THE FILTER SO HE COULD AGAIN POST DILATE THE STENT HOPING TO SLIGHTLY EXPAND THE STENT SO THE FILTER COULD THEN BE REMOVED. IT WAS AT THIS POINT HE TRIED TO REMOVE OUR ANGIOGUARD RETRIEVAL CATHETER, AND IT WOULD NOT COME BACK. AFTER MANIPULATING IT FOR A MINUTE OR SO THE CATHETER CAME BACK ONLY TO BE DISCOVERED THAT THE TIP OF THE CATHETER AND DISTAL MARKER BAND WAS DETACHED AND REMAINED ON THE WIRE IN THE BODY. WE THEN HAD TO INSERT MULTIPLE BALLOON CATHETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16106327 ↗

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-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-1484-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
• Z-1495-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
• Z-1485-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
• Z-1496-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
• Z-1491-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
• Z-1490-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
• Z-1494-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
• 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-1492-2023 · Mar 24, 2023 · Open, Classified
  ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE