Home / Recalls / Abiomed, Inc. / Z-2962-2024

Z-2962-2024 Class II Ongoing

Recalled by Abiomed, Inc. — Danvers, MA

FDA device recall Z-2962-2024 was initiated by Abiomed, Inc. on Aug 5, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 21 units.

Recall Details

Product Type: Devices
Report Date: Sep 11, 2024
Initiation Date: Aug 5, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21 units

Product Description

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

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.

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.

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;

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2962-2024
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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