Brain fluid drainage device recalled due to multiple complaints
Medtronic, a global leader in medical technology, has recently taken a few medical devices off the market as a result of multiple complaints and one reported death.
In this case, Medtronic issued a voluntary recall of the StrataMR valve and shunt.
The device was created to manage hydrocephalus – a condition where there is an accumulation of cerebrospinal fluid (CSF) within the brain. Unfortunately, concerns have been raised about the safety of the devices.
The StrataMR is designed to control the flow of fluid being drained from the brain to relieve intracranial pressure (build-up of pressure around the brain). The pressure may be as the result of a severe head injury, stroke or brain abscess. If the device is not working properly – i.e. there’s an underdrainage of fluid – it can cause headaches, nausea, vomiting and lethargy.
If it’s left untreated, it can be deadly.
One user of the Medtronic device has died, and investigations have been launched as to whether the device is responsible. However, Medtronic has yet to confirm whether or not it was linked to the underdrainage of the fluid.
Recall worldwide
According to the company, there are around 2,622 of the affected devices worldwide. The device was distributed throughout the U.K., U.S., Australia, Belgium, Canada, Finland, Germany, Hong Kong, Israel, Italy, Japan, New Zealand, Norway, Poland, Portugal, the Russian Federation, Singapore, Spain, Sweden, Switzerland, and Turkey.
The affected products were reportedly manufactured from 27th October 2015 to 11th November 2016.
So far, the recall only applies to StrataMR adjustable valves and shunts, and doesn’t apply to Strata™ II or Strata™ NSC products. However, further to an increase in product complaints, the company made a 22nd February 2017 recall on the unused medical devices.
Medtronic noted that the product’s complaint rate (as of 1st April 2017) was 2.75%.
Duty of care
There is a duty of care for companies and health regulators to ensure that medical devices are safe for patients use, and if they’re not, people have rights to make a claim.
The company has only issued a recall for unused devices for some. The company noted that if any of the affected products have been implanted in patients, physicians should refer to the recall letter dated 22nd February 2017 as well as the valve adjustment instructions for continued patient care.
Medtronic also told users and caregivers to monitor the users’ condition and, if they experience any of the symptoms listed above, they should consult the physician who implanted the StrataMR valve.
The risk can be very serious, as under-drainage can potentially lead to a comatose and death.
Medtronics’ instructions
Medtronic issued instructions to recipients in their 22nd February 2017 recall as follows:
- Stop the use of the listed product.
- Account for the number of product units implanted or discarded and return any unused units by completing an attached individualised customer product accountability form provided in the letter.
- If any the affected products have been implanted in users, to adjust the valves according to instructions listed in an included attachment.
The content of this post/page was considered accurate at the time of the original posting and/or at the time of any posted revision. The content of this page may, therefore, be out of date. The information contained within this page does not constitute legal advice. Any reliance you place on the information contained within this page is done so at your own risk.
Request a Callback from our team!
Fill out our quick call back form below and we’ll contact you when you’re ready to talk to us.
All fields marked * are required.