NAJClass IIImplant

Agents, Embolic, For Treatment Of Uterine Fibroids

Cardiovascular · 21 CFR 870.3300

MDR events477All time

Recalls1All time

Registered firms35Currently listed

510(k) clearances8All time

Recent MDR events

477 adverse event reports on file

Event type breakdown

Injury239

Other184

Malfunction34

Death18

Unspecified2

Most-reported manufacturers

*215 Unspecified124 Boston Scientific - Cork35 Boston Scientific Corporation24 Biosphere Medical, S.a.19 Biosphere Medical Sa14 Celonova Biosciences, Gmbh6 Biosphere Medical, Inc.5

Recalls

1 recall events for this product code

Boston Scientific Corporation
TerminatedSep 15, 2009
Boston Scientific, Contour SE Microspheres, for tumor treatment.
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
Z-2109-2009 · View FDA record ↗

Registered firms

35 firms currently registered for this product code

510(k) clearances

8 clearances for this product code