Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3

FDA device recall Z-2402-2026 · posted 2026-06-11 · Open, Classified

Recall details

Recalling firm: Boston Scientific Neuromodulation Corporation
Reason for recall: Reusable electrodes may not meet expected performance levels.
Action taken: On April 29, 2026, Boston Scientific issued a Urgent Medical device Removal Notification via Federal Express/email/hand delivery. Boston Scientific asked consignees to take the following actions: 1. DO NOT use affected product. Remove affected products from your facility s inventory, and segregate the units in a secure place. 2. For products already in use, immediately discard according to your facility s procedure. 3. Unused products should be returned to Boston Scientific in accordance with the enclosed instructions. 4. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. 5. Forward this notice to any healthcare professional from your organization for awareness and to any organization where affected devices have been transferred. 6. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions.
Root cause: Under Investigation by firm
Status: Open, Classified
Product code: GXI
Quantity affected: 31,923 units
Distribution: Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.
Date initiated: 2026-04-29
Date posted: 2026-06-11
Location: Valencia, CA

Recalls and clearances share one API, with change alerts when new recalls post.

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