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Abiomed is recalling the instructions for use (IFU) for its Impella left-sided blood pumps because the pump catheter may perforate the wall of the left ventricle. 

According to the recall notice, "use of the affected Impella pumps may cause serious adverse health consequences, including left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death." 

The US Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type, due to the risk for injury or death. There have been 129 reported serious injuries, including 49 reports of death.

Impella left-sided pumps are used for short-term ventricular support during high-risk percutaneous coronary interventions. Impella left-sided blood pumps are also used when there is ongoing cardiogenic shock that occurs less than 48 hours after severe acute myocardial infarction, open-heart surgery, or cardiomyopathy. 

The recall covers 66,390 devices distributed from October 10, 202, to October 10, 2023, including these devices: Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD. 

Product codes are listed in the FDA recall database. This recall is a correction, not a product removal.

An urgent medical device correction letter advises customers to adhere to these "new and revised" warnings:

• Carefully position the pump catheter during operative procedures
• Use imaging when advancing or torquing the pump catheter
• Use special care when inserting the pump catheter in patients with certain high-risk conditions or during active cardiopulmonary resuscitation
• Review the updated warnings in the device IFU
• Notify everyone at your facility who needs to be informed of this recall correction
• Notify any other facilities where the products have been forwarded of the updated IFU

Customers in the United States with questions about this recall should contact Abiomed, Inc at 978-646-1400.

Abiomed previously announced a recall of all Impella left-sided blood pumps in the United States over a potential safety issue when used in patients with a transcatheter aortic valve replacement (TAVR) stent, something that was not adequately addressed in the device IFU. 

As previously reported by Medscape Medical News, the recall involved a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, which may damage or destroy the motor's impeller blades. 

Healthcare professionals can report adverse reactions or quality problems they experience using these devices to the FDA's MedWatch program.