Recall Z-0808-2020— St Jude Medical, Cardiac Rhythm Management Division
Class II · Terminated
Class II FDA medical device recall by St Jude Medical, Cardiac Rhythm Management Division, initiated 2018-04-13, terminated 2021-02-10. It names one FDA 510(k) clearance: K163407. 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.. Reason: Devices inappropriately displayed a low battery indicator determined to be due to memory corruption..
- Recalling firm
- St Jude Medical, Cardiac Rhythm Management Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-13
- Terminated
- 2021-02-10
- Firm location
- Sylmar, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
Data sourced from openFDA. This site is unofficial and independent of the FDA.