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Every year, the Food and Drug Administration (FDA) and/or pharmaceutical and medical device manufacturers recall dozens of medical devices because they are defective and/or could be a risk to your health. If you think you’re hearing about more recalls these days, you’re right. In 2013, 63 medical devices were recalled, nearly a third more than in 2012. By March 12, 2014, there had been 12 recalls. 1
Most of the time manufacturers issue the recalls. This can be for numerous reasons, including adjusting settings on the device, relabeling the device with new warnings or information, repairing the device, or simply inspecting it for problems. The most serious type of recall is a Class 1 recall, meaning it is likely that the product could cause serious harm or even death.
So who pays when a device such as a defibrillator is recalled? In many instances, you and your insurance company. In 2006, The New York Times reported on the recall of heart defibrillators from Medtronic and Guidant, which affected about 24,000 patients. The companies gave patients (well, their doctors) new devices free, and paid up to $2,500 in out-of-pocket expenses for their replacement.
Guess who picked up the rest of the cost? The insurance company, or, if patients didn’t have insurance or their out-of-pocket costs were higher, the patient. As the Times reported, “estimates suggest the figure will mount in to the tens, if not hundreds, of millions of dollars.” A more recent example is the pacemaker/defibrillator recall from St. Jude Medical in late 2011, in which it offered a free replacement and to pay up to $600 in expenses. 2
Sometimes, a Reuters investigation found, insurance companies refuse to pay – putting the onus back on the patient to try and collect from the manufacturer or pay out-of-pocket.
Even if the company does pick up the entire cost of the removal and replacement, you still have to pay it up front and collect from the manufacturer, which may take months. You may also have travel expenses, which may not be reimbursed. Plus, doctors often aren’t aware of the reimbursement procedure, so they may not be able to counsel you on how to recoup your money.
But the cost of a recall to patients isn’t limited to money. There’s the cost of time for travel, doctor appointments, tests, and surgeries. The cost of stress, as you worry over the device that’s already within you and the procedures needed to remove and/or replace it, not to mention worrying about the permanent damage that may have occurred.
If your device is recalled, don’t panic! Call your doctor and discuss the recall. All device and pharmaceutical manufacturers are required to communicate with doctors about any recalls and their potential implications for patients. The FDA also sends out information.
And make sure you track every dollar (and hour) you spend dealing with the recall. That’s information you’ll need in the future to get reimbursed.
You can track product recalls on the FDA’s website by year, as well as report problems with medications and/or devices.
You can also sign up for up to date recall information with Recall Center’s Patient Safety Alerts.
US Food and Drug Administration. List of Device Recalls. Available at: http://www.fda.gov/medicaldevices/safety/ListofRecalls/default.htm. ↩
Weaver C. Rising Bills in St. Jude Recalls. The Wall Street Journal. August 25, 2012. Available at: http://online.wsj.com/news/articles/SB10000872396390444082904577611140680571150. ↩