Medical device manufacturer Baxter Healthcare Ltd has issued a safety alert in response to reports that the VASCU-GUARD Peripheral Vascular Patch, a device used during peripheral vascular reconstruction surgery, could cause complications.
Four reports have been received to date, detailing the need for further clinical intervention to address internal bleeding following the use of the device. In one instance a person died.
Baxter Healthcare Ltd are asking for the product to be placed in segregation, not to be used, whilst investigations take place as to any role the device may have played in the reported events.
A similar line of products by the same manufacturer was subject to a recall notice in the United States in 2015, after surgeons complained of difficulty in using the product caused by its design.
Medical device lawyer Michelle Victor from the consumer law and product safety group at Leigh Day, who is acting on behalf of hundreds of claimants affected by the failed metal on metal hip ASR DePuy and has urged for a thorough investigation to be carried out.
Ms Victor said: “Baxter Healthcare has acted correctly in issuing a statement that the device is not to be used until further investigations are carried out, but it is vital the investigations are thorough and that the precise cause of the reported bleeding is identified.
“Whenever a patient undergoes any form of surgery, they will expect their treating surgeons to be using products that are fit for purpose, and should not have to worry about such products causing more harm.”