Dealing with a Broken Heart (Device)

Products liability matters involving medical devices seriously affect the consumers that rely heavily on them to maintain their health. In this article we address defective heart devices, medical device recalls, and the appropriate steps to take if your medical device is determined to be defective or a health risk.

Defective Defibrillators

Defibrillators are electronic medical devices that deliver an electric shock to the heart to restore a normal heart beat. Defibrillators may be external or implanted and are used to treat patients experiencing dangerous arrhythmia or cardiac arrest. When an implantable or external defibrillator fails to function properly, there may be grave results. There have been significant recalls on defibrillators within the last decade by large manufacturers like Medtronic, St. Jude, and Philips.

Medical Device Recalls

Medical device recalls are issued if a device is found to be defective or a health risk. Most commonly, recalls are issued by the manufacturer upon learning their device violates a Food and Drug Administration law. The FDA will issue recalls if necessary, though it is a rare occurrence.

Recalls are categorized based on the severity of the recall being issued. The FDA classifies recalls by Class I, Class II, or Class III with Class I being the most hazardous form. Typically, recalls on heart devices are classified as Class I, due to the nature of such devices and the high risk of serious harm or death in the event of a defect. The FDA describes each class as follows:

Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.

Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.

Recently Recalled Heart Devices

Nov 2014, updated Feb 2015
Heart Sync, Multi-function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs

November 2014, updated January 2015
CONMED Corporation, PadPro and R2 Multi-Function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs

September 2014, updated January 2015
Covidien, Medi-Trace Cadence and Kendall Defibrillation Electrodes – Electrodes will Not Work with Philips FR3 and FRx Automated External Defibrillators (AEDs)

March 2014
Thoratec Corporation, HeartMate II LVAS Pocket System Controller – Insufficient Labeling and Training for Patients Switched from the EPC Controller

December 2013
HeartWare, Inc., Heartware Ventricular Assist System – Locking Mechanism of Pump Driveline Connector May Fail to Engage

View a full list of recent recalls here.

 

Next Steps

“My defibrillator was recalled, now what?”

There are many potential courses of action when a heart device is recalled depending on why the recall was issued. The FDA offers a range of actions that may be considered recalls in the following list:

  • Inspecting the device for problems
  • Repairing the device
  • Adjusting settings on the device
  • Re-labeling the device
  • Destroying device
  • Notifying patients of a problem
  • Monitoring patients for health issues

Serious recalls that require a defibrillator to be removed or replaced tend to have the greatest impact on patients with implanted devices. Implanted devices require surgical removal, presenting additional risk. However, not all recalls result in the need for a device to be removed or replaced. Often times a device simply needs to be checked, adjusted, or monitored. It is best to discuss the best course of action with a doctor or specialist when a recall is issued. Every recall is different and may require a varied degree of action.

If a recalled heart device caused serious harm or death to you or someone you love, contact a products liability attorney to help you determine a legal course of action against the device manufacturer, if necessary.

 

Sources:

https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm

https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm#RecallClassifications