Abiomed updated warnings on more than 60,000 Impella Left Sided Heart Pumps because the device might cut the wall of the heart's left ventricle, the FDA said March 21.
After 129 serious injuries, including 49 deaths, have been reported, the device company issued a correction — not a product removal — on 66,390 Impella heart pumps.
"Impella Left Sided Blood Pumps are used for short term support of the pumping chambers of the heart during high-risk catheter-based procedures called percutaneous coronary interventions," the FDA said. They "also are used when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack, open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy.
In a December letter to customers, Abiomed advised healthcare workers to carefully position the pump catheter during procedures, use imaging when moving the pump catheter, be careful with inserting the device in patients with certain high-risk conditions, review updated warnings and notify everyone who needs to know about the correction.
If the heart pump slices the left ventricle, the patient could experience left ventricle perforation, free wall rupture, hypertension, lack of blood flow or death, the FDA said.
"We have updated our instructions for use for our Impella system to further address the potential risk of a rare complication, left ventricular perforation," a company spokesperson told Becker's. "With patient safety top of mind, our IFU has been updated with stronger technical guidance around implantation and repositioning, and [it] emphasizes specific cardiac and peripheral vascular anatomic considerations when implanting Impella."
In summer 2023, Abiomed recalled about 460 Impella 5.5 with SmartAssist devices after receiving reports of fluid leaking and three injuries, and the J&J company revised instructions for its Impella Left Sided Blood Pumps after 30 complaints and 26 injuries were reported.