Medical device recalls are common. Companies typically decide to recall a device when there is a health and safety issue. Here are some of the biggest medical device recalls in recent history:
Abbott Pacemakers Recalled Because of Cyber-Security Issues
Abbot announced that it would be recalling over 500,000 pacemakers in August 2017. They were recalled because of a cyber-security flaw. This meant that the devices could have been hacked into. It was difficult to issue a recall because the devices were already implanted in the person’s chest. However, Abbot did manage to fix the cyber-security issue.
The update was approved by the Food and Drug Administration. The good news is that the patients did not suffer any harm as the result of this.
Boston Scientific Recalls the Heart Valve Products
Boston Scientific recalled its heart valve products after there were concerns raised about the locking mechanism. The issue occurred during the manufacturing process. Heart valves that were already placed in the patient did not have to be recalled.
Unfortunately, one person died after the surgeons attempted to place a second valve in the patient. The second valve caused the patient’s aorta to dissect, which lead to the person’s death. Boston Scientific released a statement that sounded rather apathetic. They stated that every other case was successful.
Abbott Recalls the Heart Pump Controllers
Abbott made another mistake that resulted in the death of 26 patients. It issued a recall of 29,000 controllers for the Heart Mate implantable heart pump. Patients had died when they tried to change controllers while they were away from the hospital. There were 70 cases reported where the controller malfunctioned.
Abbott updated the software and hardware of the controllers. Laurel Hood is the spokesperson for Abbott. She stated that there were not any products retrieved. She said that the focus is ensuring that patients are communicating with their physicians so that the controllers can be exchanged in a clinical setting. She also stated that they have updated their software and controller alerts.
Mylan had to recall 80,000 epipens. People had stated that the epipens had failed to activate. There were two cases reported where the epipen failed to activate during an emergency situation. When Mylan heard about the reports, they decided to recall the epipens. They were concerned about patient safety.
Bayer Cancels a Sterilization Device
Bayer did not recall their Essure sterilization device, but they did decide to cancel it because of the controversy it received. The device was designed to prevent pregnancy by keeping the sperm from reaching the egg. It was placed inside of the Fallopian tube.
Bayer stated that they were not concerned about the quality and safety of the product. They recalled the product for commercial reasons. However, many women reported that they experienced discomfort and pain due to the devices. Some also reported that they had to have surgery to remove their uterus.
A study showed that 12.9 percent of the women experienced pain. Nearly 30 percent of the women experienced vaginal bleeding. Nearly 7 percent of the women experienced back or pelvic comfort.
Bayer was said to withdraw the Essure device from the European market. However, the device is still available in the United States. They stated that there is no need for women to have the devices taken out, as it does not put their health at risk.
Women who have questions should consult with their doctor.
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