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.
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: 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
- Affected units
- 18
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.
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.
See all 3 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · mis labeling
See all →- ModerateEl Ruisenor De Mexico Recalls Almond Flour for Undeclared Allergen
FDA (Food) · 2026-10-28
- HighTrader Joe's Crispy Rice Milk Chocolate Bar Recalled for Undeclared Wheat
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Wheat Bran for Undeclared Wheat Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Black Sesame Seeds for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Ground Shrimp for Undeclared Allergen
FDA (Food) · 2026-10-28
Similar recalls
- HighBoston Scientific Recalls FARASTAR Ablation Generators Due to Catheter Incompatibility
FDA (Devices) · 2026-07-29
- ModerateBoston Scientific Recalls IntellaTip MiFi XP Temperature Ablation Catheters
FDA (Devices) · 2014-06-25
- SevereBoston Scientific Cardiac Catheters Recalled Due to Guidewire Advancement Failure
FDA (Devices) · 2024-05-22
- SevereBoston Scientific Recalls IntellaTip MiFi Radiofrequency Ablation Catheters
FDA (Devices) · 2015-03-11
- SevereBoston Scientific Cardiac Catheters Recalled for Material Delamination
FDA (Devices) · 2024-05-22
- ModerateBoston Scientific Recalls Small Peripheral Cutting Balloon Catheters
FDA (Devices) · 2013-09-11