Bearing nsPVA® 00884450123348Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450123348), received between Apr 21, 2026 and Apr 21, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Leak/Splash
THE CUSTOMER REPORTS THE PHYSICIAN WAS ABOUT TO PERFORM AN EMBOLISATION CASE AND THE STAFFS WAS PREPARING FOR ALL THE CONSUMABLES WHEN THEY NOTICED THAT TWO VIALS OF BEARING V400EP WAS COMPLETELY EMPTY. THE SEAL WAS NOT OPENED PRIOR TO NOTICING THE EMPTY VIAL. NO ADDITIONAL DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944543 ↗
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- Embosphere® 00884450106051Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS3 reports
- Cook G09665Cook Incorporated · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 report
- Cook G09664Cook Incorporated · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 report
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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