Boston Scientific Recalls LATITUDE Programming Systems Due to Software Defect
Boston Scientific is recalling eight Model 3300 LATITUDE Programming Systems because a software defect may cause EGM trace channels to display as a flat line during specific tests.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, and the defect is a software display issue rather than a direct physical hazard, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling eight Model 3300 LATITUDE Programming Systems that have the Model 3892 ALTRUA, INSIGNIA I, or NEXUS I Software Support Application installed. The recall is due to a potential software defect where a user changing an EGM trace channel while a Manual Pace Threshold test is in progress may cause the newly modified trace channel to change to a flat line.
The affected devices were distributed in the United States to Arkansas, Florida, Illinois, and Texas. The specific serial numbers of the affected units are 009494, 012689, 010356, 008206, 008124, 007983, 004813, and 010751. The recall is classified as Class II by the FDA.
Healthcare providers and users of these devices should contact Boston Scientific Corporation for further instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 8
Distribution
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