Home › BOSTON SCIENTIFIC CORPORATION › SpaceOAR VUE™ System - 10mL
SpaceOAR VUE™ System - 10mL
BOSTON SCIENTIFIC CORPORATION · Model SV-2101 · UDI-DI 00864661000140
OVB
Prescription
7
510(k) clearances
2,123
Adverse events (10 deaths)
2
Recalls
16
Facilities
Description
SpaceOAR Systems
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-24 | Boston Scientific Corporation | Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions |
| 2022-02-24 | Boston Scientific Corporation | Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.