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Knowing a company’s track record on medical device recalls could prove to be important when determining whether to utilize a specific medical device.
Recalls of medical devices are on the rise. In the first quarter of 2018, there were more recalls than during that same time frame in 2017. The first quarter of 2018 had a total of 208 million medical devices recalled, with over 343 actual recalls. This was a 126 percent increase from recalls in 2017. Furthermore, it was the highest number of recalls since 2005.
While any number of problems could contribute to the recall of a medical device, the leading cause in 2018 was a problem with software associated with the device. This is due in part to the increased complexity of software in the past few years. This trend is likely to continue, especially since software has remained the leading cause of device recalls for eight consecutive quarters.
Some of the other issues with medical devices which led to recalls were mislabeling, and failed specifications.
In addition to medical device recalls, there has also been an increase in pharmaceutical recalls. Foreign materials in the pharmaceutical drugs has led to a dramatic increase in the number of recalls in the industry.
In the first quarter of 2018, there were 105 recalls, with about 332.5 million units of pharmaceutical drugs recalled. Another major reason for pharmaceutical recalls was due to failed specifications, which made up 22 percent of all recalls in 2018 so far.
Reports of increases in medical device and pharmaceutical recalls were recently published by Stericycle Expert Solutions, a company that regularly tracks recalls in the medical industry.
Some recent recalls include Medtronic’s recall for Covidien Endo GIA staplers, for possible missing components. This is leading to problems with staple deployment, when medical professionals attempt to reattach tissue, and can lead to bleeding or leakage.
BD’s blood collection tubes have also been recalled due to a manufacturing fault. Another recent recall was Monteris Medical’s NeuroBlate systems, because of unexpected heating and damage to the tip of the probe.
This is just a small sample of recalls on medical devices. In the case of the stapler, a patient would not even know what type of stapler was being utilized after, for example, a surgery where the tissue was reattached with staples. Therefore, it should be recognized that anytime a person is treated by a medical professional, it could leave you vulnerable to the effects of a medical device recall, even if the device is not necessarily implanted into the body.
Medical devices are utilized in surgeries and treatments, and may not necessarily be implanted into the body. Either way, patients can recover if there has been a recall on a product. If you or someone you know has been hurt by a defective medical device as a result of a medical procedure, contact the Philadelphia Medical Device Lawyers in Philadelphia at Brookman, Rosenberg, Brown & Sandler to assist you. Call us at 215-569-4000 or contact us online.