FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
- Agency
- FDA Device
- Recall date
- Jun 11, 2026
- Status
- Ongoing
- Company
- Boston Scientific Corporation
1. What product was recalled?
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Quantity: 6 units
Code or lot text: GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
- LOT
- 1-21C-0078
- LOT
- 1-223-0099
- LOT
- 1-225-0106
- LOT
- 1-225-0107
- LOT
- 1-229-0172.
- LOT
- GTIN/UDI 00810087180126
- LOT
- Serial Numbers: 1-217-0053
- RECALL-NUMBER
- Z-2753-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
International distribution in the countries of Italy, Austria, France, Germany, Belgium.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.