Every year the FDA and MHRA recall numerous medical devices due to patient safety issues. To highlight the scope of the problem, in the US last year the FDA issued over 9,000 recalls for class I, II & III medical devices.
Product recall
MPN takes a look at some the biggest medical device recalls that have taken place over the recent years.
Abbott pacemakers recalled over cyber-security issues
In August 2017, medical device company Abbott stated that it was voluntarily recalling almost 500,000 of its pacemakers in the US due to a cyber-security flaw.
The cyber-security flaw meant that the company’s pacemakers could be hacked into with the perpetrator being able to speed-up or slow down the device.
Whilst a recall is difficult when pacemakers are embedded into patients’ chests, Abbott did manage to issue an update which fixed the cyber-security flaw.
The FDA approved the update which added authorisation to anyone attempting to access the implanted pacemaker.
Fortunately this was an instance where there were no reported causes of harm done to patients.
Boston Scientific recalls heart valve
In February 2017, Boston Scientific recalled a range of its heart valve products after the company discovered an issue with the device’s locking mechanism.
The issue was caused by excess in the pin mechanism introduced during the manufacturing process.
Any of the company’s heart valves that had been implanted in patients did not have to be recalled as the issue was the deployment of the device.
Sadly, one person died after an attempt to implant a second valve was made by surgeons, to which Boston Scientific responded with a rather apathetic sounding statement: “All affected patients were successfully treated with another valve, except for one reported case where implantation of the second valve was associated with aortic dissection and subsequent death.” A company spokesperson said.
Abbott recalls heart pump controllers
Abbott makes its way onto the list again for a recall which unfortunately resulted in 26 patients dying.
Last year, Abbott recalled around 29,000 controllers for its HeartMate II implantable heart pump after patients died when attempting to exchange controllers away from hospital.
There were a total of 70 reports of incidents related to the controller malfunctioning, according to Mass Device.
Abbott shipped new controllers for the device with updated software and hardware to help patients exchange controllers in emergencies.
Speaking about the recall, Abbott spokesperson Laurel Hood, said: “No products are being retrieved in this case; rather, the focus is on communication to physicians so they can ensure their patients have their controller exchange completed in a clinical setting. We have also updated our software and controller alerts to help patients connect with their physician’s office when they need to have their controller exchanged”.
EpiPen epidemic
Last year, drugmaker Mylan had to recall more than 80,000 EpiPens due to reports that the devices were failing to activate.
There were reports of two instances where the device failed to work in emergency situations though thankfully those involved were able to use an alternative EpiPen.
When hearing about the reports, Mylan recalled the devices, which were due to expire in April that year, due to patient safety concerns.
Bayer cancels sterilisation device
Whilst technically not a recall, Bayer’s cancellation of its Essure sterilisation device came off of the back of a lot of controversy.
The device was developed to help prevent pregnancy and is inserted into the fallopian tubes to form a barrier that keeps sperm from reaching the eggs.
Bayer stated that the decision to end sales of its product was not due to safety or product quality problem’ but was instead being made for commercial reasons.
However, the decision was also made following reports that some women were experiencing strong levels of pain and discomfort due to the devices. Some women were even reported to have had to undergo surgery to have their uterus remove.
A premarket study of the device showed that 12.9% of women experienced mild to moderate pain, 29.6% experienced vaginal bleeding and 6.8% experienced pelvic or back discomfort.
Speaking about Bayer’s decision to cancel the product, MHRA said: "Bayer has advised the Medicines and Healthcare products Regulatory Agency that they are withdrawing the Essure Device from the European Market.
The manufacturer has advised this is a commercial decision and is not related to any safety concerns and the device will continue to be available in the USA. They have also advised there is no need for women to have their device removed.
Patient safety is our highest priority and there is currently no evidence to suggest any increased risk to patient safety. Any women with questions should speak to their GP or healthcare professional.”