A manufacturing error has resulted in a Class I recall of Medtronic implantable cardiac defibrillators. The U.S. Food and Drug Administration (FDA) warns consumers that using the recalled devices could result in serious injury or death. Read on to learn more about the recalled products, and what you should do if you are impacted by one of the 48 products included.
Medtronic Recall of Implantable Cardiac Defibrillators
In January 2018, Medtronic announced a recall of Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) devices, and Implantable Cardiovert-Defibrillators (ICDs). CRT-Ds and ICDs are both implanted under the skin with wires connecting to the “leads” in the heart. The devices are most commonly used to treat patients with bradycardia (slow heart rate) or tachycardia (fast heart rate). The devices are also effective at correcting heart rate changes associated with cardiac arrest.
According to the FDA, a defect during manufacturing has caused a buildup of an “out of specification gas mixture” to form inside the device. The defect may cause the defibrillators to malfunction, failing to send the appropriate electrical shock needed to keep the patient’s heart in rhythm, or to revive a patient in cardiac arrest.
The recall affects 48 different units distributed across the United States (for a complete list, see here). Manufacturing dates range from July 2013 to August 2017. Medtronic and the FDA urge consumers who may be affected to contact their healthcare provider and Medtronic for more information. Consumers are also urged to use the MedWatch Safety Information and Adverse Event Reporting Program to report any adverse reactions or quality issues related to the affected devices.
Protect Your Rights as a Consumer
Over the past three decades, the number of recalls of products similar to the Medtronic devices have increased substantially. Any type of medical device that is implanted into the human body has risks, but those risks should not be the manufacturing process. When products are manufactured and distributed with defects it places you, the consumer, at risk for injury. Implantable devices are unique, however, because of their nature and use. It is not always possible to remove one device and replace it with another.
Furthermore, who covers the cost of the replacement item and medical expenses? What about your insurance? How do you know if your device has been recalled?
Manufacturers are required to mitigate these risks by employing quality and safety standards throughout their process. Unfortunately, manufacturing errors are common occurrences. As a consumer, it is important to understand your legal rights. If you have been injured due to a manufacturing error or product defect, contact Daic Law. Let our medical malpractice attorney help you protect your legal rights and explore your options for recovery.