FDA Device recall Z-2751-2026
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401
- FDA Device
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401 by Boston Scientific, citing labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2751-2026 |
| 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 Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Reason
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Identifiers
| code_info | GTIN 00191506042547, Serial Numbers: 106247020. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2751-2026%22
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