Boston Scientific Recalls EMBLEM S-ICD Programmer Model 3200
Boston Scientific is recalling 4,500 EMBLEM S-ICD Programmer Model 3200 units due to a potential risk of radio frequency interference causing unintended commands during in-clinic sessions.
What this means for you
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 is classified as FDA Class II. The hazard involves a risk of harm (unintended S-ICD commands) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Boston Scientific Corporation is recalling 4,500 units of the EMBLEM S-ICD Programmer Model 3200. The recall covers all serial numbers and includes devices distributed worldwide, including the United States, Canada, and numerous countries in Europe, Asia, and the Middle East.
The recall is issued because there is a potential for radio frequency (RF) interference to alter wireless communication from the programmer. In rare instances, this interference may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation or programming session with the Model 3200 programmer. There is no risk of this behavior occurring when the LATITUDE Patient Management System communicates with an S-ICD in an ambulatory setting.
Healthcare facilities and consumers who possess this device should contact Boston Scientific for further instructions on how to proceed with the recall.
The recalled product
- Product
- Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 4,500
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 (1)
- All serial numbers.
Distribution
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