FARASTAR PFA Generator, Product ID M004PFCE61M460 recallZ-2752-2026 · Boston Scientific Corporation · initiated Jun 11, 2026
Class II Open, Classified All recalls posted in July 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
FDA root cause category: Under Investigation by firm
What the company is doing
Boston Scientific issued an Urgent Field Safety Notice - Urgent Medical Device Correction notice to its consignees out side the US on 6/11/2026 via hand delivered letter. The notice explained the issue and requested the following actions be taken: Instructions: 1- Post a copy of the appropriate IFU provided near each FARASTAR PFA generator, replacing any previous versions currently in use. 2- Review the IFU and ensure all relevant personnel are aware of its contents. 3- Please complete the attached Acknowledgement Form even if you do not have any affected product and return it to your Boston Scientific office. 4- Share this communication with any healthcare professionals in your facility that use the product and with any other organization to which this product may have been transferred. The national Competent Authority was informed of this communication. Any adverse events or quality concerns associated with use of these devices should be reported to Boston Scientific and Competent Authorities if appropriate.
Recall details
- Recall number
- Z-2752-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 11, 2026
- Posted by the FDA
- Jul 17, 2026
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 11 units
- Product code
- QZI
- FDA submissions
- P230030, P230030S012
- Distribution
- International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
Product description
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Code information (models, lots, serial numbers)
GTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.
Other devices under the same FDA submission
13 devices cleared under P230030, P230030S012 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FARAWAVE™ M004PF41M401Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 recall39 deaths1,515 reports
- FARAWAVE™ NAV M004PF41M411Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths417 reports
- FARAWAVE™ M004PF41M431Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation11 deaths272 reports
- FARAWAVE™ M004PF41M402Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 deaths57 reports
- FARAWAVE™ NAV M004PF41M412Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation16 reports
- FARASTAR™ M004PF41M434Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation13 reports
- FARASTAR™ M004PF61M401Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation10 reports
- FARASTAR™ M004PF61M402Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation6 reports
- FARASTAR™ M004PF41M444Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation5 reports
- FARAPOINT™ M004PF81M110Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation1 death3 reports
- FARASTAR™ M004PF61M415Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 reports
- FARAWAVE™ M004PF41M432Boston Scientific Corporation · Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99230).
- Z-2750-2026 · Open, ClassifiedFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
- Z-2751-2026 · Open, ClassifiedFARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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