Recall archive / FDA device enforcement
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cat... — FDA record Z-2753-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 11, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Classification
- Class II
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 6 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2753-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the countries of Italy, Austria, France, Germany, Belgium.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 29, 2026
- Recall initiation date
- Jun 11, 2026
- Center classification date
- Jul 17, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.