Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FFR Link-FFR Signal Processing Module Recalled by Boston Scientific Corporation Due to The device history record (DHR) was missing its...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
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
Quantity: 3
Why Was This Recalled?
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Where Was This Sold?
US Distribution to one customer in Missouri.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report