Boston Scientific FARASTAR PFA Generator recalled for catheter incompatibility
Boston Scientific identified specific FARASTAR Pulsed Field Ablation (PFA) generators with a configuration that cannot work safely with the FARAPOINT PFA catheter. Six units with specific serial numbers were distributed across Europe and need to be replaced.
From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls
What to do
- If you operate or manage a cardiac ablation facility with a FARASTAR PFA generator, check if your serial number matches: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, or 1-229-0172
- Contact Boston Scientific for a replacement generator if your serial number is affected
- Do not use an incompatible FARASTAR generator with the FARAPOINT catheter
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 6 units
- Illnesses reported
- None reported
- Manufactured in
- 4100 Hamline Ave N, N/A, Saint Paul, MN, United States
- Classification
- Class II
- Recall number
- Z-2753-2026
In the FDA's words
- Description
- FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172. Distribution: International distribution in the countries of Italy, Austria, France, Germany, Belgium. Affected quantity: 6 units
- Hazard
- Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
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