# FDA recall Z-0033-2018

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

## Product

Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W.  The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System.  These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry.  The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit.  The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician.  The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.

## 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-0033-2018
- **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-0033-2018

## Citation

> AI Analytics. FDA recall Z-0033-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0033-2018. Source: US FDA. Licensed CC0.

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