The FDA recalled Boston Scientific’s EMBLEM S-ICD, an implantable cardioverter-defibrillator, in December after receiving reports of numerous injuries and one death due to device failure.

Boston Scientific initiated the implantable cardioverter defibrillator recall on Dec. 2 following 27 complaints surrounding device failure. These reports included 26 instances of serious injuries and one death. According to the FDA’s recall announcement, the Boston Scientific S-ICD may fail due to an issue with the device’s subcutaneous electrode­—the metal arm branching off the device to detect irregular heartbeats.

Unlike other ICDs, Boston Scientific’s S-ICD does not use electrodes implanted directly into the heart or surrounding blood vessels. Instead, the therapy provided by the device influences the heart from outside the heart using a “subcutaneous electrode.”

Unfortunately, according to the recent Boston Scientific recall announcement, this vital part of the ICD can become unusable. A portion of this electrode can fracture and impact the device’s ability to deliver treatments.

When an implantable cardioverter defibrillator works correctly, the device is able to deliver electric pulses to the heart. These devices may be used for the treatment of arrhythmias—heartbeat patterns which are too fast, too slow, or otherwise irregular. The electric pulse provided by an ICD shocks the heart back to a regular rhythm and helps avoid life threatening complications.

A malfunctioning or damaged ICD fails to provide this necessary therapy—as with the now-recalled Boston Scientific S-ICD. If a patient’s S-ICD is damaged, an irregular heartbeat may continue. An untreated arrhythmia can lead to heart failure, stroke, heart attack, and death.

This risk for life threatening complications and death prompted Boston Scientific to recall over 19,000 of their EMBLEM S-ICD devices.

Due to the recall, patients may have to make significant changes in order to adjust to their new risk for complications. Doctors have been directed to screen patients for defects with their devices through at-home monitoring using Boston Scientific Latitude screening and in-office follow up appointments every three months. In cases where device fracture is detected through alerts, signal errors, or imaging, patients may need further surgery to replace the damaged ICD.

FDA Recalls: What Can I Do?

The FDA is responsible for recalling food, supplements, medications, and medical devices which are defective, contaminated, or misbranded. When a medical device such as the Boston Scientific S-ICD is recalled, or their transvaginal mesh products which were allegedly associated with complications, the FDA helps coordinate a response, notify healthcare providers, and inform patients how they may be affected.

Although FDA recalls help to take defective or dangerous products off the market, patients may still be injured or killed by defective devices before a recall is announced. This is evidenced by reports of injuries or reports predating a recall – such as the 27 reports seen with the Boston ICD device.

No amount of compensation can reverse the damage patients may have sustained, but patients and bereaved loved ones may be eligible to take legal action for injuries sustained because of recalled devices. This includes patients who were injured by Boston Scientific’s now recalled S-ICD device.