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SpaceOAR System
BOSTON SCIENTIFIC CORPORATION · Model SO-2101 · UDI-DI 00864661000102
OVB
Prescription
7
510(k) clearances
2,123
Adverse events (10 deaths)
2
Recalls
16
Facilities
Description
The SpaceOAR System consists of components for preparation of a synthetic, absorbable hydrogel spacer and a delivery system packaged for single use.
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 |
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