FARASTAR PFA Generator and Cardiac Ablation Catheter Recalled Due to Labeling Discrepancy
Boston Scientific Corporation is recalling 11 units of FARASTAR PFA Generators and Percutaneous Cardiac Ablation Catheters because the Instructions For Use did not include FARAPOINT PFA catheter information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The FDA has classified this as a Class II recall, which involves a situation where the probability of adverse health consequences is remote or for which the consequences are generally less severe.
Plain-English summary
Boston Scientific Corporation is recalling 11 units of FARASTAR PFA Generator (Product ID M004PFCE61M460) and Percutaneous Cardiac Ablation Catheter.
The recall was initiated due to a labeling discrepancy where the provided Instructions For Use (IFU) did not include information regarding the FARAPOINT PFA catheter.
This recall affects international distribution in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, and Ireland. Affected units include serial numbers 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, and 109892816.
The recalled product
- Product
- FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 11
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 (12)
- GTIN 00191506043643
- Serial Numbers: 106205893
- 106450787
- 107392777
- 107476023
- 108017345
- 108521214
- 108577158
- 108695934
- 109072152
- 109484718
- 109892816.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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