# FDA recall Z-0038-2018

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

## Product

PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP  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-0038-2018
- **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-0038-2018

## Citation

> AI Analytics. FDA recall Z-0038-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0038-2018. Source: US FDA. Licensed CC0.

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