FDA Medical Device Recalls (openFDA)
Checkpoint Surgical Inc: 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.
- Recall number
- Z-1466-2025
- Recalling firm
- Checkpoint Surgical Inc
- 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 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.
- Status
- Open, Classified
- Initiated
- 2025-02-24
- Posted
- 2025-03-26
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 135
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI B13095240 Small Lot 4318 Expires 01Apr2026 Lot 4325 Expires 01Apr2026 Lot 4368 Expires 01Dec2026
- 510(k) numbers
- ["K212355"]
- PMA numbers
- not on file
- Product code
- ETN
- Firm FEI
- 3012222873
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28