FDA recall, , Moderate risk
Boston Scientific FARASTAR Ablation Generator and Cardiac Ablation Catheter
The Farastar Ablation Generator has a configuration not compatible with the Farapoint catheter.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation, of Saint Paul, Minnesota, is replacing specific FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator units, Product ID 61M401, because the configuration is not compatible for use with the FARAPOINT PFA catheter. The company began the recall on June 11, 2026, and the FDA added it to its Enforcement Report on July 17, 2026. The affected units were distributed internationally in Italy, Austria, France, Germany, and Belgium.
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?
Affected if its UDI-DI matches.
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
Recall details
- Company began the recall
- Sold in
International distribution in the countries of Italy, Austria, France, Germany, Belgium.
- Company
- Boston Scientific CorporationSaint Paul, Minnesota
- Hazard
- Device defect
- 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
- 99251
- Recall number
- Z-2753-2026
- Quantity recalled
- 6 units
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
