Boston Scientific Corporation: Medical Device Recall in 2017 - (Recall #: Z-3132-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 15, 2017

Date Posted: September 20, 2017

Recall Number: Z-3132-2017

Event ID: 77444

Reason for Recall:

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

Status: Terminated

Product Quantity: 3

Code Information:

Lot/Batch No. (Exp Date): SPM01975 (09/05/2044), SPM00890 (09/27/2043), SPM01616 (06/28/2044)

Distribution Pattern:

US Distribution to one customer in Missouri.

Voluntary or Mandated:

Voluntary: Firm initiated