CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
Farastar Ablation Generator EU recalled by Boston Scientific
Boston Scientific is recalling Farastar Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401. The recall was initiated on 11 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2753-2026
- FDA event ID
- 99251
- Recalling firm
- Boston Scientific, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Jun 2026
- FDA classified
- 17 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 11 Jun 2026 | Recall initiated by company | |
| 17 Jul 2026 | Classified by FDA | +36 days |
| 29 Jul 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Where it was distributed
International distribution in the countries of Italy, Austria, France, Germany, Belgium.
Questions about this recall
Why was it recalled?
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Which lots are affected?
GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
Where was it sold?
International distribution in the countries of Italy, Austria, France, Germany, Belgium.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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