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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- 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:
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