Abiomed, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2967-2024)

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:

ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;

Product Classification:

Class II

Date Initiated: August 5, 2024

Date Posted: September 11, 2024

Recall Number: Z-2967-2024

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: 8 units

Code Information:

Product Code: 1000302; UDI-DI: 00813502012767; Serial Numbers: 392664 392661 392660 392665 392666 392667 392668 392669; Batch Numbers: 2023263121 2023263124 2023263125 2023269641 2023269670 2023269672 2023269673 2023269674;

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