Checkpoint Guardian Lead (Checkpoint Surgical) – Adhesive Encapsulation Fault (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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, allowin
Brand
Checkpoint Surgical Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI B13095240 Small Lot 4318 Expires 01Apr2026 Lot 4325 Expires 01Apr2026 Lot 4368 Expires 01Dec2026
Checkpoint Surgical Inc is recalling Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026