Agents, Embolic, For Treatment Of Uterine Fibroids
FDA adverse event reports and recall history for agents, embolic, for treatment of uterine fibroids (product code NAJ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 477
- Deaths
- 18
- Injuries
- 239
- Malfunctions
- 34
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2009-09-15TerminatedProcess design
Boston Scientific, Contour SE Microspheres, for tumor treatment. UPN Codes: Description: M001761101 Contour SE/100-300/1mL/2vials M001761122 Contour SE/100-300/1mL/5vials M001761141 Contour SE/100-300/2mL/2vials M001761162 Contour SE/100-300/2mL/5vials M001761201 Contour SE/300-500/1mL/2vials M001761222 Contour SE/300-500/1mL/5vials M001761241 Contour SE/300-500/2mL/2vials M001761262 Contour SE/300-500/2mL/5vials M001761301 Contour SE/500-700/1mL/2vials M001761322 Contour SE/500-700/1mL/5vials M001761341 Contour SE/500-700/2mL/2vials M001761362 Contour SE/500-700/2mL/5vials M001761401 Contour SE/700-900/1mL/2vials M001761422 Contour SE/700-900/1mL/5vials M001761441 Contour SE/700-900/2mL/2vials M001761462 Contour SE/700-900/2mL/5vials M001761501 Contour SE/900-1200/1mL/2vials M001761522 Contour SE/900-1200/1mL/5vials M001761541 Contour SE/900-1200/2mL/2vials M001761562 Contour SE/900-1200/2mL/5vials
Compromised sterility: Boston Scientific is initiating a Recall Removal for twenty (20) UPN codes and 638 associated lots/batches of its Contour SE Microspheres product. All affected product is packaged within a vial. Boston Scientific has determined that, for affected products, the sterile barrier in the packaging (pouch) that contains the vial may be breached. The breach of sterility could l
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