Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
St. Jude Medical Confirm Rx Insertable Cardiac Monitor Recalled by Abbott Due to The device is unable to pair with the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott directly.
Affected Products
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.
Quantity: 32 devices
Why Was This Recalled?
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Abbott
Abbott has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report