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
This recall has been terminated (originally issued July 5, 2011).
- Company
- St Jude Medical Crmd
- Recall Initiated
- March 31, 2011
- Posted
- July 5, 2011
- Terminated
- July 19, 2011
- Recall Number
- Z-2733-2011
- Quantity
- 83 units
- Firm Location
- Sylmar, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the devices sensing algorithm. These enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. The user is presented with the option to upgrade new software into the SJM Confirm ICM
Distribution
Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany
Lot / Code Info
Confirm DM2100, DM2102 (IDE). Software Version 10.1.1.2
Root Cause
Software change control
Action Taken
St. Jude Cardiac Rhythm Management Division sent an "Important Product Correction" letter on March 25, 2011 to all affected customers. The letter explains the reason for the recall and provided recommendations including a software upgrade by SJM Field Clinical Engineer or Technical Services. Customers were recommended to fill out and return a "Physician Acknowledgement Form". For additional information please contact your local St.Jude Medical Sales Representative, Field Clinical Engineer or the Technical Services Department at 800-722-3774