Recall Z-1220-2019— Abbott

Name: FDA recall Z-1220-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-19

Class II · Terminated

Class II FDA medical device recall by Abbott, initiated 2018-11-19, terminated 2021-04-28. It names one FDA 510(k) clearance: K163407. 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.. Reason: The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired..

Recalling firm: Abbott
Classification: Class II
Status: Terminated
Initiated: 2018-11-19
Terminated: 2021-04-28
Firm location: Sylmar, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.·cleared 2017-09-29

K-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

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.