Z-2733-2011

SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less...

Name: Z-2733-2011 SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less...
Creator: St Jude Medical CRMD
Published: 2011-03-31
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-03-31 / Terminated / root cause: software

FDA source

St Jude Medical CRMD began a recall of SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is... on 2011-03-31. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2733-2011
Status: Terminated
Initiated: 2011-03-31
Posted: 2011-07-05
Terminated: 2011-07-19
Recalling firm: Abbott Medical
Product: 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
Product code: MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
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
Root cause tag: software
FDA root cause: Software change control
Action: 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
Quantity in commerce: 83 units
Distribution: Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany
Product codes and lots: Confirm DM2100, DM2102 (IDE). Software Version 10.1.1.2

Product code MXC

K081365Class IISjm Confirm Model Dm2100 Implantable Cardiac Monitor and Model Dm2100a Patient ActivatorSt Jude Medical / cleared 2008-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)