Lower risk Medical device recall · FDA · Published November 19, 2018

St. Jude Medical Confirm Rx Cardiac Monitor Fails to Pair with App

St. Jude Medical Confirm Rx Insertable Cardiac Monitor (REF DM3500) fails to pair with mobile app due to certificate expiration error. Affected units have serial numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1220-2019Medical device St. Jude Medical ›

Lower-risk recall

The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.

Take action

Contact the company

Recalling firmAbbott15900 Valley View Ct · Sylmar, CA 91342-3577

✎ GovInfoNow plain-language explainer

Abbott is recalling St. Jude Medical Confirm Rx Insertable Cardiac Monitors (REF DM3500) because they cannot pair with the mobile app due to a certificate expiration error. This issue does not pose a health risk but may prevent proper monitoring of heart conditions. Read more at govinfonow.com/recall/69455-st-jude-medical-confirm-rx-cardiac-monitor-fails-to-pair.

Source Summary by GovInfoNow · govinfonow.com/recall/69455-st-jude-medical-confirm-rx-cardiac-monitor-fails-to-pair · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1220-2019

Cite this page

“St. Jude Medical Confirm Rx Cardiac Monitor Fails to Pair with App.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69455-st-jude-medical-confirm-rx-cardiac-monitor-fails-to-pair. Based on FDA recall #Z-1220-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1220-2019%22&limit=1).

The FDA announced on 2018-11-19 that Abbott is recalling St. Jude Medical Confirm Rx Insertable Cardiac Monitor REF DM3500 devices because they cannot pair with the mobile app due to an incorrect certificate expiration determination.

How to tell if you have it

Brand: St. Jude Medical
Product: Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile
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
Quantity: 32 devices
Distribution: US Nationwide in AZ, CA, CO, ID, IL, LA, MA, MI, MO, NE, NH, NJ, NY, TN, TX, and WI

The hazard

The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.

Context

GovInfoNow's records show Abbott has 12 other recalls on record since 2018-04-05. Other recent recalls of similar products include Boston Scientific LUX-DX II Arrythmia Detector Recall (2026-03-30), Boston Scientific LUX-Dx Cardiac Monitor System Recall (2026-08-06), and Boston Scientific LUX-Dx II Plus Model M312: Incorrect Heart Monitoring Risk (2026-03-30).

How to tell if you have this one

Check if your device has the serial numbers listed in the recall notice: 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, 9256057.

Brand
St. Jude Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Identify your device's serial number and compare it to the list of affected numbers provided in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 16 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Idaho, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Hampshire, New Jersey, New York, Tennessee, Texas, Wisconsin.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

Nov 19, 2018Firm started the recall
Apr 25, 2019FDA classified it Class II
May 1, 2019Published in FDA’s Enforcement Report
Apr 28, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if my device is affected?

The recall does not require immediate action. Check the device's serial number and contact Abbott for further guidance if needed.

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Link to this recall

<a href="https://govinfonow.com/recall/69455-st-jude-medical-confirm-rx-cardiac-monitor-fails-to-pair">St. Jude Medical Confirm Rx Cardiac Monitor Fails to Pair with App (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1220-2019 (November 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1220-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.