Checkpoint Surgical Inc. is recalling 587 units of its Checkpoint Guardian Intraoperative Leads in Small and Medium sizes. The adhesive on the back of the surgical leads may fail to completely cover the internal metal wiring, which can cause electrical current to leak. While no injuries have been reported, this defect may result in inconsistent muscle responses during surgery, potentially causing a surgeon to take an incorrect clinical action. These devices were distributed nationwide to hospitals and surgical centers.
The exposed metal on the lead assembly creates a risk of electrical current leakage during nerve stimulation. This can lead to confusing or inaccurate responses from the patient's muscles, which may cause the surgeon to misinterpret nerve function and perform an incorrect surgical procedure.
Single-patient disposable accessory for providing stimulus to a targeted nerve.
Single-patient disposable accessory for providing stimulus to a targeted nerve.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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