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FARASTAR™
BOSTON SCIENTIFIC CORPORATION · Model M004PF41M444 · UDI-DI 00191506041663
QZI
Prescription
0
510(k) clearances
8,980
Adverse events (210 deaths)
6
Recalls
45
Facilities
Description
Catheter Connection Cable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-11 | Boston Scientific Corporation | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. |
| 2026-06-11 | Boston Scientific Corporation | Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. |
| 2026-06-11 | Boston Scientific Corporation | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. |
| 2026-06-11 | Boston Scientific Corporation | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. |
| 2025-06-25 | Boston Scientific Corporation | The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end. |
| 2025-01-05 | Biosense Webster, Inc. | Due to an observed trend of neurovascular events |
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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.