Recall Z-1467-2025

Checkpoint Surgical Inc · initiated February 24, 2025

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

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.

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

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.

FDA-determined 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.

Details

Recall number
Z-1467-2025
Initiated
February 24, 2025
Posted by FDA
March 26, 2025
Product code
ETN – Stimulator, Nerve
Quantity
452
Distribution
US Nationwide distribution.
Recalling firm
Checkpoint Surgical Inc, Cleveland, OH

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1466-2025 Class IIBrand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian…Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button… 02/24/2025Open, Classified