Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/Catalog Number: REF# 9524 (Small) 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.
This recall is currently active, issued March 26, 2025. It was issued by Checkpoint Surgical Inc.
- Company
- Checkpoint Surgical Inc
- Recall Initiated
- February 24, 2025
- Posted
- March 26, 2025
- Recall Number
- Z-1466-2025
- Quantity
- 135
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI-DI B13095240 Small Lot 4318 Expires 01Apr2026 Lot 4325 Expires 01Apr2026 Lot 4368 Expires 01Dec2026
Root Cause
Process control
Action Taken
The recalling firm alerted affected hospitals by visit on February 24, 2025. Customers were asked to check inventory for affected lot numbers and to return the affected inventory for replacement. Notifications were issued on February 26, 2025.