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Terminated

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

FDA Recall Z-3132-2017 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDRG
Date Initiated2017-05-15
Date Terminated2021-07-06
Product Quantity3

Reason for Recall

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

Firm Action

Boston Scientific sent an Important Medical Device Information letter dated May 30, 2017, to their affected consignee. On May 15, 2017, Boston Scientific visited the consignee and exchanged the affected device for a device that met specifications. The letter requested a response form be completed and returned. For questions customers should call 763-494-1133.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US Distribution to one customer in Missouri.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170204FFR Link, FFR Signal Processing ModuleBoston Scientific Corporation · 2017-03-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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