FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- 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: 18 units
Code or lot text: GTIN 00810087180126, Serial Numbers: 102174748, 103355157, 103432386, 103480452, 103547915, 103836571, 1-215-0040, 1-226-0123, 1-227-0129, 1-228-0139, 1-22C-0216, 1-234-0276, 1-237-0307, 104015648, 104993721, 1-233-0266, 1-236-0305, 1-237-0307.
- LOT
- 1-215-0040
- LOT
- 1-226-0123
- LOT
- 1-227-0129
- LOT
- 1-228-0139
- LOT
- 1-22C-0216
- LOT
- 1-233-0266
- LOT
- 1-234-0276
- LOT
- 1-236-0305
- LOT
- 1-237-0307.
- LOT
- 103355157
- LOT
- 103432386
- LOT
- 103480452
- LOT
- 103547915
- LOT
- 103836571
- LOT
- 104015648
- LOT
- 104993721
- LOT
- GTIN 00810087180126
- LOT
- Serial Numbers: 102174748
- RECALL-NUMBER
- Z-2750-2026
FARASTAR PFA Generator, Product ID M004PFCE61M460
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Quantity: 11 units
Code or lot text: GTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.
- LOT
- 106450787
- LOT
- 107392777
- LOT
- 107476023
- LOT
- 108017345
- LOT
- 108521214
- LOT
- 108577158
- LOT
- 108695934
- LOT
- 109072152
- LOT
- 109484718
- LOT
- 109892816.
- LOT
- GTIN 00191506043643
- LOT
- Serial Numbers: 106205893
- RECALL-NUMBER
- Z-2752-2026
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Quantity: 1 units
Code or lot text: GTIN 00191506042547, Serial Numbers: 106247020.
- LOT
- GTIN 00191506042547
- LOT
- Serial Numbers: 106247020.
- RECALL-NUMBER
- Z-2751-2026
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?
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
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 states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
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.