Abiomed, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2962-2024)

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 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;

Product Classification:

Class II

Date Initiated: August 5, 2024

Date Posted: September 11, 2024

Recall Number: Z-2962-2024

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: 21 units

Code Information:

Product Code: 0550-0004; UDI-DI: 00813502010466; Serial Numbers: 439898 437211A 437204A 440938 439938 439939 453784 453785 476355 476356 470678 493496 493497 491749 491752 491751 478569A 483483A 491750 485277A 485281A; Batch Numbers: 2024337828 2024338391 2024338394 2024340273 2024341579 2024341586 2024356969 2024356971 2024397878 2024397886 2024399646 2025440057 2025440061 2025448005 2025452639 2025452668 2025484262 2025484276 2025448006 2025500661 2025500668;

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