Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL...
Reason for Recall / Hazard
Reusable electrodes may not meet expected performance levels.
Product Description & Identification
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)
Affected Products
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)
Additional Source Details
| Field | Value |
|---|---|
| City | Valencia |
| State | CA |
| Event id | 98939 |
| Address 1 | 25155 Rye Canyon Loop |
| Address 2 | N/A |
| Code info | 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; |
| Postal code | 91355-5004 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 31,923 units |
| Reason for recall | Reusable electrodes may not meet expected performance levels. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260429 |
| Initial firm notification | Letter |
| Center classification date | 20260611 |
Overview
- Recalling FirmBoston Scientific Neuromodulation Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.