Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Mode

Summary

The FDA issued a Class II for Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Gu by Checkpoint Surgical Inc. Reason: Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed met.

Details

Product Description

Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing stimulus to a targeted nerve. The accessories are intended for use with any device from the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a targeted nerve.

Lot/Code Info: UDI-DI B13095250 Medium Lot 4322 Expires 01Apr2026 Lot 4326 Expires 01Apr2026 Lot 4333 Expires 01Jul2026 Lot 4352 Expires 01Jul2026

Quantity Affected: 452

Reason for Recall

Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-02-24

Company