# FDA recall Z-2750-2026

> **Boston Scientific Corporation** · Class II · device recall initiated 2026-06-11.

## Product

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

## Reason for recall

Labeling discrepancy:  Devices distributed with Instructions For Use (IFU) did not include  FARAPOINT PFA catheter information.

## Distribution

International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.

## Key facts

- **Recall number:** Z-2750-2026
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-11
- **Report date:** 2026-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2750-2026

## Citation

> AI Analytics. FDA recall Z-2750-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2750-2026. Source: US FDA. Licensed CC0.

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