FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
USFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Recalling Firm: Boston Scientific Corporation
Reason for Recall / Hazard
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Product Description & Identification
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Additional Source Details
| Field | Value |
|---|---|
| City | Saint Paul |
| State | MN |
| Event id | 99230 |
| Address 1 | 4100 Hamline Ave N |
| Address 2 | N/A |
| Code info | 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. |
| Postal code | 55112-5700 |
| Report date | 20260729 |
| Product type | Devices |
| Product quantity | 18 units |
| Reason for recall | Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260611 |
| Initial firm notification | Letter |
| Center classification date | 20260717 |
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Overview
- Recalling FirmBoston Scientific Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionInternational distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
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🚨 SAFETY ALERT: Boston Scientific Corporation - FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Check if your household is affected: https://therecallfile.com/recalls/farastar-ablation-generator-eu-pulsed-field-ablation-generator-product/FDA-Z-2750-2026
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