Class 1 Recall Issued for Boston Scientific S-ICD Lead

Patients with a Boston Scientific S-ICD should be aware of a Class I recall of the 3501 Emblem subcutaneous electrode.  This model was manufactured from March 2016 through November 2020.
 
 
This same issue was the subject of a product advisory issued in December of 2020, but due to 26 serious injuries and one death associated with the device, the advisory was upgraded to a recall.   
 
 
Boston Scientific has a product lookup tool (www.BostonScientific.com/lookup) where you can look up your device and see if your specific lead is affected.  You can find your serial numbers on your registration card.
 
 
You can read the HCMBeat’s previous entry on this issue here. 
 

Boston Scientific Advisories for S-ICD Patients

Patients with a Boston Scientific S-ICD should be aware of two recent product advisories.
 
 
There is an advisory for early battery depletion in the S-ICD generator, and there is a separate advisory pertaining to the 3501 lead.
 
 
Boston Scientific has a product lookup tool (www.BostonScientific.com/lookup) where you can look up your device and see if your specific generator and/or lead are affected.  You can find your serial numbers on your registration card.
 
 
The product advisories can be found here: https://www.bostonscientific.com/…/product-advisories.html