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Sterile Interface Cable

Biosense Webster Inc · Model D133701 · UDI-DI 10846835010121

QZI Prescription

510(k) clearances

9,992

Adverse events (238 deaths)

Recalls

Facilities

Description

Cath to Generator CBL Sterile

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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Data 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.