Z-1220-2019Class II

St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile

Name: Z-1220-2019 St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile
Creator: Abbott
Published: 2018-11-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-11-19 / Terminated / root cause: software

FDA source

Abbott began a recall of St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is... on 2018-11-19. FDA classified it as Class II and gives the reason as "The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1220-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-19
Posted: 2019-04-25
Terminated: 2021-04-28
Recalling firm: Abbott Medical
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.
Product code: MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Reason for recall: The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Root cause tag: software
FDA root cause: Software design
Action: Abbott sent an Important Medical Device Correction letter dated November 20, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Should you have questions about this issue, contact your local Abbott Representative or Abbott Support at 1-800-727-7846 (Opt3) (U.S.), 8:30am - 5:30pm Central Time Monday thru Friday.
Quantity in commerce: 32 devices
Distribution: US Nationwide Distribution in the states of AZ, CA, CO, ID, IL, LA, MA, MI, MO, NE, NH, NJ, NY, TN, TX, and WI.
Product codes and lots: Serial numbers 9225191, 9224501, 9225179, 9225193, 9225207, 9242209, 9257638, 9257646, 9257656, 9257659, 9224508, 9224490, 9224503, 9224525, 9224529, 9225190, 9225203, 9225205, 9225208, 9225211, 9225214, 9225851, 9225855, 9225858, 9225859, 9225867, 9225868, 9242199, 9242219, 9242225, 9242231, and 9256057.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1220-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1220-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-25

Product code MXC

K163407Class IIConfirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. / cleared 2017-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)