Checkpoint Guardian Intraoperative Lead, Small recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide distribution.

Nationwide