ASAP® 00884450437261Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450437261), received between Nov 24, 2020 and Feb 24, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Difficult to Advance” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult to Advance1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2021Material Integrity Problem; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING AN ASPIRATION PROCEDURE, THE DISTAL END OF THE ASPIRATION CATHETER FRACTURED WITHIN THE PATIENT. ALL FOREIGN BODY OBJECTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. NO ADDITIONAL CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11373583 ↗InjuryNov 24, 2020Difficult to Advance; Difficult to Advance
THE ACCOUNT ALLEGES THAT DURING AN EMERGENT PROCEDURE, AN INTERVENTIONAL GUIDEWIRE BECAME STUCK WITHIN THE ASPIRATION CATHETER FORMIN A LOOP. THE PHYSICIAN WAS FORCED TO REMOVE ALL INTERVENTIONAL EQUIPMENT AND MAKE A SECOND ATTEMPT IN TREATING THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10897325 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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