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Boston Scientific FARASTAR PFA Generator
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MEDICAL DEVICE RECALLMODERATE

Boston Scientific FARASTAR PFA Generator

Boston Scientific is recalling FARASTAR PFA generators (Product ID 61M401) due to incompatibility with the FARAPOINT PFA catheter.

What to do

Healthcare providers should immediately stop using the affected FARASTAR PFA generators with FARAPOINT PFA catheters and contact Boston Scientific for replacement units.

Recalled
Listed
Updated
Recall No.
Z-2753-2026
Agency
FDA
Firm
Boston Scientific Corporation
Recall ID
99251
Status
ONGOING

Recall at a glance

Quantity recalled
6 units

Why it was recalled

Boston Scientific is recalling specific FARASTAR Pulsed Field Ablation (PFA) generators because they possess a configuration that is incompatible for use with the FARAPOINT PFA catheter. The affected units are identified by Product ID 61M401.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

UDI-DI
00810087180126

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-07-20 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification