Reported Sep 20, 2017 · Terminated
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- 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
- Lot codes and dates
- Lot/Batch No. (Exp
- Date)
SPM01975 (09/05/2044)SPM00890 (09/27/2043)SPM01616 (06/28/2044)
- Amount recalled
- 3
Where it was sold
Why it was recalled
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
This product could cause temporary or reversible health problems — stop using it.
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