# FDA recall Z-3132-2017

> **Boston Scientific Corporation** · Class II · device recall initiated 2017-05-15.

## Product

FFR Link-FFR Signal Processing Module, Material Number H7495551000  It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable

## Reason for recall

The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.

## Distribution

US Distribution to one customer in Missouri.

## Key facts

- **Recall number:** Z-3132-2017
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-15
- **Report date:** 2017-09-20
- **Termination date:** 2021-07-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3132-2017

## Citation

> AI Analytics. FDA recall Z-3132-2017. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-3132-2017. Source: US FDA. Licensed CC0.

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