Boston Scientific Recalls CLEARSIGN II Amplifiers Due to ECG Signal Interference
Boston Scientific is recalling 43 CLEARSIGN II Amplifiers because blood pressure channel usage can cause ECG signals to become uninterpretable.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a functional defect can lead to uninterpretable diagnostic signals, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 43 units of the CLEARSIGN II Amplifier for the LABSYSTEM PRO EP Recording System. The affected devices use firmware version 2.08 and are available in 40, 80, 120, and 160-channel configurations. The recall covers specific catalog and lot numbers distributed worldwide to countries including Austria, Belgium, France, Germany, Great Britain, Greece, Italy, Netherlands, Poland, Romania, South Africa, Spain, Switzerland, and Turkey. There was no distribution in the United States.
The recall was initiated after Boston Scientific received complaints indicating that using the blood pressure channels on the amplifier causes the surface Electrocardiogram (ECG) channels to become over-written. This results in the ECG signal appearing shifted from baseline on the system's output screen, which may manifest as an uninterpretable ECG signal in the affected channel.
The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer for recording and display. Users of the affected devices should stop using the blood pressure channels to prevent potential ECG signal interference.
The recalled product
- Product
- CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 43
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 (20)
- Catalog number 2002021: lot numbers: EPYL0080
- EPYL0118
- EPZA0061
- EPZA0072
- EPZA0073
- EPZA0074
- EPZB0043
- EPZC0019
- EPZC0026
- EPZC0027
- Catalog number 2002022: lot numbers: EPYL0031
- EPYL0032
- EPYL0033
- EPYL0034
- EPYL0035
- EPYL0036
- EPYL0037
- EPYL0038
- EPYL0039
- EPZA0062
Distribution
Distribution scope not specified by the agency.
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