Boston Scientific Recalls FARASTAR Ablation Generators Due to Catheter Incompatibility
Boston Scientific is replacing specific FARASTAR PFA generators that are not compatible with the FARAPOINT PFA catheter. The FDA Class II recall affects 6 units distributed internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a medical device with configuration incompatibility that creates a risk of harm during cardiac ablation procedures, though no injuries have been reported.
Plain-English summary
Boston Scientific Corporation is recalling 6 units of the FARASTAR Ablation Generator EU (Product ID 61M401), a pulsed field ablation generator used with percutaneous cardiac ablation catheters. The recall is necessary because specific units have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
The affected units have GTIN/UDI 00810087180126 and serial numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172. Distribution occurred in Italy, Austria, France, Germany, and Belgium.
Healthcare facilities and patients using these specific generator-catheter combinations should contact Boston Scientific immediately. The company will replace the incompatible units. No illnesses or injuries have been reported in connection with this issue.
For questions, contact Boston Scientific Corporation through their official channels. This recall is identified as FDA Class II and is listed under recall number Z-2753-2026.
The recalled product
- Product
- FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 6
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- GTIN/UDI 00810087180126
- Serial Numbers: 1-217-0053
- 1-21C-0078
- 1-223-0099
- 1-225-0106
- 1-225-0107
- 1-229-0172.
Distribution
Distribution scope not specified by the agency.
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