# FDA recall Z-2335-2018

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

## Product

Merlin PCS Programmer Software: 3330    The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.

## 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-2335-2018
- **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-2335-2018

## Citation

> AI Analytics. FDA recall Z-2335-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2335-2018. Source: US FDA. Licensed CC0.

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