FARASTAR Ablation Generator EU recall (Boston Scientific Corporation)
Medical deviceClass IIOngoing
Summary: Boston Scientific Corporation is recalling FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter. Reason: Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
What is being recalled
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Why
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
International distribution in the countries of Italy, Austria, France, Germany, Belgium.
How to tell if yours is affected
GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2753-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 11, 2026 |
| Reported | July 29, 2026 |
| Company | Boston Scientific Corporation |
| Company location | Saint Paul, MN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 6 units |
More recalls from Boston Scientific Corporation · all medical device recalls · recalls from June 2026