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Abbott recalls St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Con
Recalled May 1, 2019 · FDA recall Z-1220-2019 · Abbott
Hazard
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired. · FDA Class II
Units
32 devices
Sold at
US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, LA, MA, MI, MO, NE, NH, NJ, NY, TN, TX, and WI.
Description
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
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.
Manufacturer(s)
Abbott
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →