Urgent Medical Device Recall EMBLEMTM S-ICD Subcutaneous Implantable Defibrillators (S-ICDs) (Model A209 and A219)

Field Safety Notice

Boston Scientific is recalling approximately 150 Model A209 and A219 EMBLEMTM S-ICDs worldwide due to an incorrect manufacturing date/timestamp within the software, causing an inaccurate display of battery capacity.

The affected devices have a manufacturing date/timestamp that causes the initial battery capacity displayed after exiting storage mode to be approximately 10%. The battery capacity value will decrement non-linearly and inaccurately over the device’s implant life.

Retrieval Action

Immediately discontinue use of the affected devices and remove them from inventory. Segregate the units in a secure place, pending return to Boston Scientific.

Complete the attached Verification Form and return it to your local Boston Scientific office by 10 October 2022.

Manual:

Download: Urgent Medical Device Recall EMBLEMTM S-ICD Subcutaneous Implantable Defibrillators (S-ICDs) (Model A209 and A219)

Chat: Powered By VoiceSphere