Boston Scientific Recalls FFR Link Signal Processing Modules for Missing Test Records
Boston Scientific is recalling three FFR Link Signal Processing Modules because the device history record was missing documentation for final electrical testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation issue (missing test records) rather than a physical defect or reported harm, consistent with the rubric for documentation issues.
Plain-English summary
Boston Scientific Corporation is recalling three units of the FFR Link-FFR Signal Processing Module, Material Number H7495551000. The device is intended to condition physiological signals from measuring devices, transmit and receive via radiofrequency, and recondition the signals for display or recording on a receiving device.
The recall was initiated because the device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing. The affected units are identified by the following lot numbers and expiration dates: SPM01975 (09/05/2044), SPM00890 (09/27/2043), and SPM01616 (06/28/2044).
The devices were distributed in the United States to one customer in Missouri. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- 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 c
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Cardiology
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot/Batch No. (Exp Date): SPM01975 (09/05/2044)
- SPM00890 (09/27/2043)
- SPM01616 (06/28/2044)
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
Same hazard · documentation issue
See all →- LowBMC Medical Luna G3 APAP Devices Recalled for Retroactive Rework Reporting
FDA (Devices) · 2026-08-26
- LowFARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information
FDA (Devices) · 2026-07-29
- ModerateFARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy
FDA (Devices) · 2026-07-29
- LowPenner bathing spa 350010 series recalled for lacking unique device identifier
FDA (Devices) · 2026-03-18
- LowPenner bathing spa models recalled for lacking a unique device identifier
FDA (Devices) · 2026-03-18