St. Jude Medical, Inc. Recall: Infinity 7, Implantable Pulse Generator, REF 6663, Rx only,
St. Jude Medical, Inc. Recall: Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: St. Jude Medical, Inc.; Product: Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an elect
| Recalling firm | St. Jude Medical, Inc. |
|---|---|
| Product | Infinity 7, Implantable Pulse Generator, REF 6663, 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 accommod |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US Nationwide Distribution |
| Recall initiated | 20170602 |
| Recall number | Z-2696-2017 |
| Category | device |
| State | TX |
| Country | United States |
$29/mo
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