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# Boston Scientific EMBLEM Electrode Recall is Class 1
- URL: https://www.fdaweb.com/boston-scientific-emblem-electrode-recall-is-class-1/
- Published: 2021-02-02T12:00:00.000Z
- Updated: 2026-09-14T16:44:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148579

FDA says a Boston Scientific 12/2/20 recall of 19,919 EMBLEM S-ICD subcutaneous electrodes is Class 1\. A recall [notice](https://www.fda.gov/medical-devices/medical-device-recalls/boston-scientific-recalls-emblem-s-icd-subcutaneous-electrode-model-3501-due-risk-fractures?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the electrodes are part of the Boston Scientific S-ICD implantable cardioverter defibrillator system.

The company recalled the electrodes due to an increased risk of fractures at a point distal to the proximal sense ring. “If the device fractures during use,” the notice says, “it could become unable to deliver therapy to slow very fast heartbeat from cardiac arrest. A failed device may cause serious adverse events.”

There have been 27 complaints about the device issue with 26 reports of serious injuries and one reported death, the notice says.