Checkpoint Guardian Intraoperative Lead adhesive defect electrical leakage risk
The adhesive on Checkpoint Guardian Intraoperative Leads may not fully cover metallic wire components, leading to potential electrical current leakage. This could result in inconsistent muscle responses and affect surgical effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with potential risk-of-harm in surgical context. Although no illnesses or injuries have been reported, the electrical leakage hazard could compromise nerve localization effectiveness and potentially cause incorrect surgical action.
Plain-English summary
Checkpoint Surgical Inc is recalling Checkpoint Guardian Intraoperative Leads, Small (Model REF# 9524). The products are single-patient disposable surgical accessories designed to provide electrical stimulus to targeted nerves during surgery. Approximately 135 units were distributed nationwide in the United States.
The recall was issued because the adhesive on the back of the leads may not fully encapsulate the metallic portion of the wire and button subassembly, potentially exposing metal components. This defect creates a risk of electrical current leakage during surgical use.
If electrical current leaks, it may result in inconsistent or confusing muscle responses during nerve stimulation. This could compromise the effectiveness of nerve localization, potentially causing the surgeon to take an incorrect clinical action during the procedure.
Affected lots include: Lot 4318 (expires April 1, 2026), Lot 4325 (expires April 1, 2026), and Lot 4368 (expires December 1, 2026), with UDI-DI B13095240. Healthcare facilities should identify and quarantine affected units and contact Checkpoint Surgical Inc for instructions on return or replacement.
The recalled product
- 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 s
- Manufacturer
- Checkpoint Surgical Inc
- Hazard
- electrical-leakage
- device-malfunction
- muscle-response-failure
Distribution
Distributed nationwide across the United States.
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