FDA Medical devices recall ·
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401 recall
- Recall number
- Z-2751-2026
- Date
- (initiated June 11, 2026)
- Company / brand
- Boston Scientific Corporation
4100 Hamline Ave N, Saint Paul, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Why was it recalled?
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN 00191506042547, Serial Numbers: 106247020.
Distribution
International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2751-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.