Checkpoint Surgical Inc: Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description:

Hazard

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.

Details from the source

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. Quantity: 452 Lot/code info: UDI-DI B13095250 Medium Lot 4322 Expires 01Apr2026 Lot 4326 Expires 01Apr2026 Lot 4333 Expires 01Jul2026 Lot 4352 Expires 01Jul2026

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.