Company: St Jude Medical, Cardiac Rhythm Management Division
Date of Enforcement Report: 1/22/2020
Class II
PRODUCT
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. – Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM 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.
- Recall Number: Z-0808-2020
REASON
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
RECALLING FIRM/MANUFACTURER
St Jude Medical, Cardiac Rhythm Management Division on 4/13/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,906 impacted ICMs
DISTRIBUTION
U.S. Nationwide and International