—#156068

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

FDA product code: DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K170204
Affected lot / code info: Lot/Batch No. (Exp Date): SPM01975 (09/05/2044), SPM00890 (09/27/2043), SPM01616 (06/28/2044)

Why it was recalled

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

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: US Distribution to one customer in Missouri.

Timeline

Recall initiated: 2017-05-15
Terminated: 2021-07-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156068. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.