Bearing nsPVA® 00884450123317Recalls & 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 00884450123317), received between Apr 8, 2026 and Apr 8, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Clumping in Device or Device Ingredient” (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
- Clumping in Device or Device Ingredient1
- Component Missing1
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 8, 2026Clumping in Device or Device Ingredient; Component Missing
THE CUSTOMER REPORTED THAT DURING PREPARATION OF BEARING NSPVA, THE OPERATOR FOUND THAT THE VIAL WAS EMPTY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820066 ↗
Other AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS devices
- Embosphere® 00884450116715Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 recall8 reports
- HydroPearl HP2S0600Microvention, Inc. · Agents, embolic, for treatment of uterine fibroids1 recall0 reports
- Embosphere® 00884450109519Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 recall0 reports
- Embosphere® 00884450098424Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS8 reports
- Embosphere® 00884450098561Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS8 reports
- Embosphere® 00884450106051Biosphere Medical · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS3 reports
- Cook G09665Cook Incorporated · AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS1 report
- Bearing nsPVA® 00884450123348Merit Medical Systems, Inc. · 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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