Checkpoint Surgical Inc: Device Recall

Recall Details

Recall Number

Z-1467-2025

Classification

Class II

Product Type

Device

Recalling Firm

Checkpoint Surgical Inc

Status

Ongoing

Date Initiated

02/24/2025

Location

Cleveland, OH, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

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.

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.

Distribution Pattern

US Nationwide distribution.

Other Recalls by Checkpoint Surgical Inc

• Class II: Risk 02/24/2025
  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.

View all recalls by Checkpoint Surgical Inc →