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U.S. Department of Health and Human Services

Class 2 Device Recall St. Jude Medical Confirm Rx Insertable Cardiac Monitor

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  Class 2 Device Recall St. Jude Medical Confirm Rx Insertable Cardiac Monitor see related information
Date Initiated by Firm November 19, 2018
Date Posted April 25, 2019
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-1220-2019
Recall Event ID 82536
510(K)Number K163407  
Product Classification Recorder, event, implantable cardiac, (without arrhythmia detection) - Product Code MXC
Product St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile.

Product Usage:
The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
Code Information Serial numbers 9225191, 9224501, 9225179, 9225193, 9225207, 9242209, 9257638, 9257646, 9257656, 9257659, 9224508, 9224490, 9224503, 9224525, 9224529, 9225190, 9225203, 9225205, 9225208, 9225211, 9225214, 9225851, 9225855, 9225858, 9225859, 9225867, 9225868, 9242199, 9242219, 9242225, 9242231, and 9256057.
Recalling Firm/
Manufacturer		 Abbott
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Mr. Justin Paquette
651-756-6293
Manufacturer Reason
for Recall		 The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
FDA Determined
Cause 2		 Software design
Action Abbott sent an Important Medical Device Correction letter dated November 20, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Should you have questions about this issue, contact your local Abbott Representative or Abbott Support at 1-800-727-7846 (Opt3) (U.S.), 8:30am - 5:30pm Central Time Monday thru Friday.
Quantity in Commerce 32 devices
Distribution US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, LA, MA, MI, MO, NE, NH, NJ, NY, TN, TX, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MXC and Original Applicant = St. Jude Medical, Inc.
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