Boston Scientific reusable CSK stainless steel electrodes may underperform expected levels
Boston Scientific CSK stainless steel electrodes across several lengths are being recalled because the reusable electrodes may not meet expected performance levels. 31,923 units affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall describing an unquantified performance shortfall with no failure mode or clinical consequence stated, which fits the precautionary Moderate band.
Plain-English summary
Boston Scientific CSK Electrodes are being recalled, covering REF CSK-TC10, CSK-TC15 and the other stainless steel electrode lengths listed in the recall notice, along with their 3M cable variants. The action covers 31,923 units across all lots.
The stated reason is that the reusable electrodes may not meet expected performance levels. The FDA classified the action as Class II. The source does not describe a specific failure mode or clinical consequence.
Distribution was worldwide, including nationwide in the United States and to Peru, Mexico, Puerto Rico, Colombia and Malaysia. The electrodes are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF numbers and UDI codes in the recall notice and follow the instructions issued by Boston Scientific.
The recalled product
- 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-TC15-3
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Category
- Medical Device — Electrode
- Affected units
- 31,923
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Neuromodulation Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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