FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
USFARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; 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 Pulsed Field Ablation Generator, Product ID M004PFCE61M401; 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 00191506042547, Serial Numbers: 106247020. |
| Postal code | 55112-5700 |
| Report date | 20260729 |
| Product type | Devices |
| Product quantity | 1 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 Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter Check if your household is affected: https://therecallfile.com/recalls/farastar-pulsed-field-ablation-generator-product-id-m004pfce61m401-per/FDA-Z-2751-2026
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