# FDA recall Z-2334-2018

> **St Jude Medical Inc.** · Class II · device recall initiated 2018-04-16.

## Product

St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500    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

The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.

## Distribution

U.S. Nationwide Distribution: PR, MI, NJ, IL, FL, AR, PA, KY, CA, TN, IN, AL, TX, AZ, SC, OK, VA, NH, NM, WA, CO, IA, WI, NV, UT, OH, NC, MO, DE, WV, MD, OR, NE, VT, KS, MA, IA, WY, CT, GA, MS, LA, DC, LA,

## Key facts

- **Recall number:** Z-2334-2018
- **Recalling firm:** St Jude Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-16
- **Report date:** 2018-07-11
- **Termination date:** 2021-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sylmar, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2334-2018

## Citation

> AI Analytics. FDA recall Z-2334-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2334-2018. Source: US FDA. Licensed CC0.

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