Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)

Confirm DM2100, DM2102 (IDE). Software Version 10.1.1.2

Cardiovascular Devices

2

Yes

Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany

SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). || This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia