Abiomed, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2957-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;

Product Classification:

Class II

Date Initiated: August 5, 2024

Date Posted: September 11, 2024

Recall Number: Z-2957-2024

Event ID: 95129

Reason for Recall:

A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.

Status: Ongoing

Product Quantity: 9 units

Code Information:

Product Code: 0048-0040; UDI-DI: 00813502011739; Serial Numbers: 370089 370091 370090 370074 370093 401804 401805 401811 401806; Batch Numbers: 2023172492 2023172497 2023172494 2023172500 2023172499 2023255511 2023255513 2023255522 2023255514

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated