Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Small Model/C
FDA device recall Z-1466-2025 · posted 2025-03-26 · Open, Classified
Recall details
- Recalling firm
- Checkpoint Surgical Inc
- 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.
- Action taken
- The recalling firm alerted affected hospitals by visit on February 24, 2025. Customers were asked to check inventory for affected lot numbers and to return the affected inventory for replacement. Notifications were issued on February 26, 2025.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- ETN
- Quantity affected
- 135
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-02-24
- Date posted
- 2025-03-26
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large (K212355) | Checkpoint Surgical | 2021-08-26 |