FFR Link-FFR Signal Processing Module — Class II medical device recall Z-3132-2017
Terminated recall by Boston Scientific Corporation, reported 2017-09-20, distributed in MO. The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical
| Recall number | Z-3132-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2017-05-15 |
| Classified | 2017-09-13 |
| Reported by FDA | 2017-09-20 |
| Terminated | 2021-07-06 |
| Distributed | MO |
| Quantity | 3 |
| Lot numbers | SPM00890, SPM01616, SPM01975 |
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
Reason for recall
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3132-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.