# FDA recall Z-0032-2018

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

## Product

Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1  The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.

## 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-0032-2018
- **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-0032-2018

## Citation

> AI Analytics. FDA recall Z-0032-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0032-2018. Source: US FDA. Licensed CC0.

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