# FDA recall Z-2695-2017

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

## Product

Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO    Product Usage:  The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. 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-2695-2017
- **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-2695-2017

## Citation

> AI Analytics. FDA recall Z-2695-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2695-2017. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*