FDA Medical Device Recalls (openFDA)
Boston Scientific Neuromodulation Corporation: Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 15 cm x 28 ga (0.36 mm) REF: CSK-TC20, CSK Electrode, STAINLESS STEEL, 20 cm x 28 ga (0.36 mm) REF: CSK-TC5,CSK Electrode, STAINLESS STEEL, 5 cm x 28 ga (0.36 mm); REF: CSK-TC5-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 5 cm x 28 ga (0.36 mm)
- Recall number
- Z-2402-2026
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Product
- Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 15 cm x 28 ga (0.36 mm) REF: CSK-TC20, CSK Electrode, STAINLESS STEEL, 20 cm x 28 ga (0.36 mm) REF: CSK-TC5,CSK Electrode, STAINLESS STEEL, 5 cm x 28 ga (0.36 mm); REF: CSK-TC5-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 5 cm x 28 ga (0.36 mm)
- Status
- Open, Classified
- Initiated
- 2026-04-29
- Posted
- 2026-06-11
- Terminated
- not on file
- Reason
- Reusable electrodes may not meet expected performance levels.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 31,923 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.
- Lot, serial or model codes
- All Lots: / UDI: CSK-TC10:00813250010107; CSK-TC10-3M: 00813250011524; CSK-TC15 00813250010114; CSK-TC15-3M: 00813250011548 CSK-TC20: 0081325001140; CSK-TC5: 00813250010091; CSK-TC5-3M: 00813250011531;
- 510(k) numbers
- ["K050084","K183177"]
- PMA numbers
- not on file
- Product code
- GXI
- Firm FEI
- 3006630150
- Firm city
- Valencia
- Firm state
- CA
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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