Home / Recalls / Abiomed, Inc. / Z-2457-2026

Z-2457-2026 Class I Ongoing

Recalled by Abiomed, Inc. — Danvers, MA

Recall Details

Product Type
Devices
Report Date
June 24, 2026
Initiation Date
May 18, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 units

Product Description

Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.

Reason for Recall

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

Distribution Pattern

US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan

Code Information

GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).

Other recalls by Abiomed, Inc.

  • 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)
  • Z-1471-2026 Class I — Impella RP. Product Code: 0046-0011. (January 27, 2026)
  • Z-1469-2026 Class I — Impella RP with SmartAssist. Product Code: 0046-0035. (January 27, 2026)
  • Z-1030-2026 Class II — Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. (December 4, 2025)
  • Z-0069-2026 Class I — Automated Impella Controller (AIC), used for left heart support blood pump, labe (October 1, 2025)
  • Z-0136-2026 Class I — Automated Impella Controller (AIC) labeled as the following with corresponding P (September 16, 2025)