# FDA recall Z-0035-2018

> **St Jude Medical Inc.** · Class II · device recall initiated 2017-08-28.

## Product

PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST  These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart.  These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

## Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-0035-2018
- **Recalling firm:** St Jude Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-28
- **Report date:** 2017-10-25
- **Termination date:** 2020-07-08

- **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-0035-2018

## Citation

> AI Analytics. FDA recall Z-0035-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0035-2018. Source: US FDA. Licensed CC0.

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