Infinity 5 — Class II medical device recall Z-2693-2017
Terminated recall by St. Jude Medical, Inc., reported 2017-07-19, distributed nationwide. The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electros
| Recall number | Z-2693-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Inc., Plano, TX, United States |
| Recall initiated | 2017-06-02 |
| Classified | 2017-07-07 |
| Reported by FDA | 2017-07-19 |
| Terminated | 2022-08-24 |
| Distributed | Nationwide (US) |
| Quantity | 443 units |
| Model numbers | 6660 |
Product
Infinity 5, Implantable Pulse Generator, REF 6660, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2693-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.