FDA recall, , Moderate risk
Boston Scientific FARASTAR Ablation Generators and Cardiac Ablation Catheters
Farastar ablation generators and catheters have labeling that does not include Farapoint PFA catheter information.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation of Saint Paul, Minnesota began a recall of Farastar Ablation Generator EU, Farastar Pulsed Field Ablation Generator, and Farastar PFA Generator on June 11, 2026. The FDA added the recall to its Enforcement Report and classified it on July 17, 2026, noting a labeling discrepancy where the Instructions For Use did not include FARAPOINT PFA catheter information.
The devices were distributed internationally in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, and Ireland.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
- UDI-DI
- 00810087180126
- 102174748
- 103355157
- 103432386
- 103480452
- 103547915
- 103836571
- 104015648
- 104993721
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
- UDI-DI
- 00191506042547
- 106247020
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
- UDI-DI
- 00191506043643
- 106205893
- 106450787
- 107392777
- 107476023
- 108017345
- 108521214
- 108577158
- 108695934
- 109072152
- 109484718
- 109892816
Recall details
- Company began the recall
- Sold in
International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
- Company
- Boston Scientific CorporationSaint Paul, Minnesota
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99230
- Recall numbers
- Z-2750-2026 to Z-2752-2026
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
