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 August 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
September 11, 2024
Initiation Date
August 5, 2024
Termination Date
N/A
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;

Other recalls by Abiomed, Inc.

  • Z-2600-2026 Class I — Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro (May 22, 2026)
  • Z-2602-2026 Class I — Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14 (May 22, 2026)
  • Z-2599-2026 Class I — Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro (May 22, 2026)
  • Z-2601-2026 Class I — Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14 (May 22, 2026)
  • Z-2457-2026 Class I — Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 004 (May 18, 2026)
  • Z-2360-2026 Class I — Automated Impella Controller (AIC), for use with left heart support blood pump. (May 14, 2026)
  • Z-2211-2026 Class I — Automated Impella Controller (AIC); Product Code: 0042-0000-US; (April 20, 2026)
  • Z-1589-2026 Class I — Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled (February 18, 2026)
  • Z-1591-2026 Class I — Automated Impella Controller (AIC), labeled as the following with corresponding (February 16, 2026)
  • Z-1470-2026 Class I — Impella RP Flex with SmartAssist. Product Code: 1000323. (January 27, 2026)

FDA data resources