Merit Advance® 00884450008188Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 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 00884450008188), received between Feb 22, 2023 and Feb 23, 2023 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
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 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THE PATIENT SUFFERED A SKIN INFECTION. THE INFECTION WAS RESOLVE USING IV ANTIBIOTIC THERAPY. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16429074 ↗InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THE PATIENT SUFFERED A SKIN INFECTION. THE INFECTION WAS RESOLVE USING IV ANTIBIOTIC THERAPY. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16423236 ↗
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- NA EP003994SMedtronic, Inc. · Trocar60 reports
- Cook G02364Cook Incorporated · Trocar1 recall5 reports
- HeartSpan® 00884450489345Merit Medical Systems, Inc. · Trocar1 recall1 death2 reports
- Cook G01377Cook Incorporated · Trocar1 recall2 reports
- Cook G02365Cook Incorporated · Trocar1 recall0 reports
- Endrys G19261Cook Incorporated · Trocar1 recall0 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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