FDA recently warned about a serious risk of heart perforations from Impella pumps, due to faulty instructions that may have resulted in more than 100 injuries and nearly 50 deaths
FDA indicates that a recent update to the instructions constitutes a Class I recall, since problems with the Impella Blood Pumps can lead to severe injury or death
This is the third Impella heart pump recall issued in recent months, following reports of injuries and deaths due to device failures.
At least four deaths have been linked to problems with the Impella Left Side Blood Pumps, which could suffer motor blade damage when placed near TAVR valves.
The FDA has given the Impella heart pump recall a class I designation, meaning the problems could cause severe patient injuries and deaths.
FDA says Abiomed Impella RP Heart Pump Systems are safe enough to use, but must be limited to specific patient populations.
