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BioProtect Balloon Implant™ System
BIOPROTECT LTD · Model 5135 · UDI-DI 07290014878020
OVB
Prescription
8
510(k) clearances
2,123
Adverse events (10 deaths)
2
Recalls
16
Facilities
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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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.