FDAFDA recall Z-2753-2026 · Jul 29, 2026
Boston Scientific Corporation: FARASTAR Ablation Generator EU recall
Recall found
Product
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Reason for recall
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
- Quantity
- 6 units
- Distribution
- International distribution in the countries of Italy, Austria, France, Germany, Belgium.
- Recalling firm
- Boston Scientific Corporation, Saint Paul, MN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-11
Source: openFDA enforcement record Z-2753-2026 · search recall number Z-2753-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.