FARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy
Boston Scientific is recalling 18 FARASTAR Ablation Generator EU devices due to missing FARAPOINT PFA catheter information in the Instructions For Use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with labeling discrepancy; no injuries or illnesses reported; classified as minor labeling error per rubric criteria for documentation issues.
Plain-English summary
Boston Scientific Corporation is recalling 18 units of the FARASTAR Ablation Generator EU (Product ID 61M401), a pulsed field ablation generator used with percutaneous cardiac ablation catheters. The recall affects devices distributed in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, and Ireland.
The hazard is a labeling discrepancy where the Instructions For Use (IFU) provided with the devices did not include information about the FARAPOINT PFA catheter. This documentation issue could potentially affect proper device use.
No illnesses, injuries, or deaths have been reported in connection with this recall. Consumers who own or use the affected devices should contact Boston Scientific immediately to obtain corrected documentation and follow the updated instructions.
The recalled product
- Product
- FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- mis-labeling
- documentation-issue
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- 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.
Distribution
Distribution scope not specified by the agency.
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