CLASS II Device recall · Reported 20 Sep 2017 · FDA Enforcement Report
FFR Link-FFR Signal Processing Module recalled by Boston Scientific
Boston Scientific is recalling FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to, distributed in Missouri. The recall was initiated on 15 May 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3132-2017
- FDA event ID
- 77444
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2017
- FDA classified
- 13 Sep 2017
- Reported
- 20 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 15 May 2017 | Recall initiated by company | |
| 13 Sep 2017 | Classified by FDA | +121 days |
| 20 Sep 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Product as listed by the FDA
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
Where it was distributed
US Distribution to one customer in Missouri.
Questions about this recall
Is FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to recalled?
Yes. Boston Scientific recalled FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to on 15 May 2017. The recall is Class II and its status is Terminated. Recall number Z-3132-2017.
Why was it recalled?
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Which lots are affected?
Lot/Batch No. (Exp Date): SPM01975 (09/05/2044), SPM00890 (09/27/2043), SPM01616 (06/28/2044)
Where was it sold?
US Distribution to one customer in Missouri.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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