Checkpoint Guardian Intraoperative Lead: Potential Electrical Exposure Risk
Adhesive may not fully encapsulate metallic components on Checkpoint Guardian Intraoperative Leads, creating potential for electrical current leakage. This could cause inconsistent muscle responses and incorrect surgical actions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device with potential for serious harm in a surgical context. While no injuries have been reported, exposed electrical components in an intraoperative device could compromise surgical effectiveness and lead to incorrect clinical actions during a procedure.
Plain-English summary
Checkpoint Surgical Inc is recalling the Checkpoint Guardian Intraoperative Lead, Medium (REF# 9525) due to a potential adhesive failure. The adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leaving metal components exposed.
When metal components are exposed, there is a risk of electrical current leakage. This may lead to inconsistent or confusing muscle responses during surgery, potentially compromising the device's effectiveness and leading a surgeon to take an incorrect clinical action.
Approximately 452 units were distributed nationwide under lot numbers 4322, 4326, 4333, and 4352.
The recalled product
- 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…
- Manufacturer
- Checkpoint Surgical Inc
- Affected units
- 452
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Checkpoint Surgical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Checkpoint Surgical Inc
See all →- HighCheckpoint Guardian Intraoperative Lead adhesive defect electrical leakage risk
FDA (Devices) · 2025-04-02
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