FDA Device recall Z-2753-2026
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401
- FDA Device
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401 by Boston Scientific, citing boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2753-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-11 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Reason
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Identifiers
| code_info | GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Boston Scientific
- NaviFlex LW Pusher
FDA Device · Class II · 2026-10-21 · Boston Scientific - Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5
FDA Device · Class I · 2026-09-30 · Boston Scientific - Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable,…
FDA Device · Class II · 2026-09-23 · Boston Scientific - LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
FDA Device · Class II · 2026-09-09 · Boston Scientific - LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
FDA Device · Class II · 2026-09-09 · Boston Scientific
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2753-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.