FDA issues Class 2 recall of PNE Lead Implant Kit

FDA action · FDA · 2026-10-17. Number 1 in the UrologyWatch Top 5 for October 18, 2026.

FDA has classified a recall of a percutaneous nerve evaluation (PNE) lead implant kit as Class 2, a device category used in sacral neuromodulation testing for voiding dysfunction.

Why it matters: Urologists using PNE leads for sacral neuromodulation trials should check whether affected lots are in their inventory.

Source: FDA

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