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FARASTAR Ablation Generator and FARAPOINT Catheter
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MEDICAL DEVICE RECALLMODERATE

FARASTAR Ablation Generator and FARAPOINT Catheter

Boston Scientific recalls FARASTAR generator and ablation catheter due to missing IFU info for FARAPOINT catheter.

What to do

If you have a FARASTAR Ablation Generator EU or a Percutaneous Cardiac Ablation Catheter, stop using the device and contact Boston Scientific for a corrected Instructions For Use. Do not use the device until you have received the updated labeling.

Recalled
Listed
Updated
Recall No.
Z-2750-2026
Agency
FDA
Firm
Boston Scientific Corporation
Recall ID
99230
Status
ONGOING

Why it was recalled

Boston Scientific is recalling the FARASTAR Ablation Generator EU and the Percutaneous Cardiac Ablation Catheter because the Instructions For Use (IFU) distributed with the devices did not include information about the FARAPOINT PFA catheter. This labeling discrepancy may lead to improper use of the catheter, potentially causing serious patient harm.

Is mine affected?

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

ProductRecall #UDI-DI
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation CatheterZ-2750-202600810087180126, 102174748, 103355157, 103432386, 103480452, 103547915, 103836571, 104015648, 104993721
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation CatheterZ-2751-202600191506042547, 106247020
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation CatheterZ-2752-202600191506043643, 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816

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 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification