# FDA recall Z-2692-2017

> **St. Jude Medical, Inc.** · Class II · device recall initiated 2017-06-02.

## Product

Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO    Product Usage:  The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.

## Reason for recall

The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2692-2017
- **Recalling firm:** St. Jude Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-02
- **Report date:** 2017-07-19
- **Termination date:** 2022-08-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plano, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2692-2017

## Citation

> AI Analytics. FDA recall Z-2692-2017. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2692-2017. Source: US FDA. Licensed CC0.

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