Abiomed is recalling the instructions for use of its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. The FDA has identified this as a Class I recall-- the most urgent type of recall-- where use of or exposure to a violative product will cause serious adverse health consequences or death.
The recalled devices include:
- US Available Product Names: Impella 2.5; Impella CP; Impella CP with SmartAssist; Impella 5.0; Impella 5.5 with SmartAssist ; Impella LD
- Product Codes: See Recall Database Entry
- Distribution Dates: October 10, 2021 to October 10, 2023
During operations, the recalled Impella device could cut through the wall of the left ventricle. Use of the pumps could cause left ventricle perforation or free wall rupture, hypertension, lack of blood flow, and death. The FDA stated that there have been 129 reported serious injuries, including 49 reports of death.
Customers of Impella devices should have received an Urgent Medical Device Correction letter from Abiomed on December 27, 2023. The letter requested customers adhere to the following 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 CPR
- Review the updated warnings in the device’s Instructions for Use
- Notify everyone at your facility who needs to be informed of this recall correction
- Notify any other facilities where the products have been forwarded the updated Instructions for Use
If you have questions about this recall, contact Abiomed, Inc. at (978) 646-1400. To report a problem, complete the FDA reporting form.