Abiomed, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2113-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Impella LD intravascular micro axial blood pump, Product Number 005082

Product Classification:

Class I

Date Initiated: June 14, 2023

Date Posted: July 26, 2023

Recall Number: Z-2113-2023

Event ID: 92321

Reason for Recall:

There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.

Status: Ongoing

Product Quantity: 9252 units

Code Information:

UDI-DI: 00813502011227;

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated