Sorin Group Italia Issues Field Safety Notice Concerning Heart Valves

Affected Products May Contain Endocarditis-Causing Bacteria

19.08.2014

An urgent field safety notice (FSN) has been issued by Sorin Group Italia after risks were identified relating to its Perceval S Aortic and Pericarbon More Mitral prosthetic heart valves.

The company has recalled a number of the products after it discovered Corynebacterium spp. bacteria may be present on valves used in heart operations. 

The serial numbers of the products affected are available from the Medicines and Healthcare Products Regulatory Agency (MHRA) website.

If a contaminated valve is implanted patients may develop infectious endocarditis, a very serious condition that can lead to death in some cases. As a result of the dangers posed to patients, Sorin Group Italia has voluntarily recalled all the affected products.

Medical professionals have been asked to identify all unused heart valves identified in the FSN and to return them to the manufacturer. Heart surgeons and cardiologists responsible for patients who have had these valves implanted have been urged closely monitor patients and consult with infectious disease specialists where necessary.

If you or a loved one has been injured or fallen ill due to a faulty medical device or medicine, our medical negligence claims team could help you claim compensation. View our Defective Medical Device & Medicines Claims page for more information.


Expert Opinion
We have acted for a number of patients who have suffered as a result of problems with medical equipment and devices which have been fitted in hospitals by medical professionals. Patient care should always be a top priority, which means ensuring the medical devices used in surgical procedures meet the highest possible standards.

“The heart valves were sterilised for use in hospitals, but it has subsequently been discovered that this particular bacterium was not monitored during the process. Therefore, some of the valves produced may contain bacteria that could put patients’ lives at risk.

“It is vital the manufacturer identifies failings within its testing procedures to ensure incidents such as this, where patients are being put in danger, are avoided in the future. It will be necessary for the manufacturer to investigate how the contamination occurred and consider adapting its quality assurance process in order to protect patients further. It is crucial all medical devices that make it to market and used within hospitals and operating theatres are safe.”
Kevin Timms, Solicitor