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
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
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 | 99251 |
| Address 1 | 4100 Hamline Ave N |
| Address 2 | N/A |
| Code info | GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172. |
| Postal code | 55112-5700 |
| Report date | 20260729 |
| Product type | Devices |
| Product quantity | 6 units |
| Reason for recall | Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. |
| 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 countries of Italy, Austria, France, Germany, Belgium.
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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-2753-2026
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