Z-3132-2017Class II

FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological...

Name: Z-3132-2017 FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological...
Creator: Boston Scientific Corporation
Published: 2017-05-15
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-05-15 / Terminated

FDA source

Boston Scientific Corporation began a recall of FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure... on 2017-05-15. FDA classified it as Class II and gives the reason as "The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3132-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-15
Posted: 2017-09-13
Terminated: 2021-07-06
Recalling firm: Boston Scientific Corporation
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
Product code: DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Reason for recall: The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
FDA root cause: Unknown/Undetermined by firm
Action: 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.
Quantity in commerce: 3
Distribution: US Distribution to one customer in Missouri.
Product codes and lots: Lot/Batch No. (Exp Date): SPM01975 (09/05/2044), SPM00890 (09/27/2043), SPM01616 (06/28/2044)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3132-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3132-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-20	2017-09-13

Product code DRG

K170204Class IIFFR Link, FFR Signal Processing ModuleBoston Scientific Corporation / cleared 2017-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)