Home / Recalls / Abiomed, Inc. / Z-1470-2026

Z-1470-2026 Class I Ongoing

Recalled by Abiomed, Inc. — Danvers, MA

Recall Details

Product Type
Devices
Report Date
March 11, 2026
Initiation Date
January 27, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,496 units

Product Description

Impella RP Flex with SmartAssist. Product Code: 1000323.

Reason for Recall

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.

Code Information

Product Code: 1000323. UDI-DI: 00813502012811.

Other recalls by Abiomed, Inc.

  • 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)
  • Z-2568-2025 Class I — Automated Impella Controller (AIC) with the below brands and product codes. Used (August 20, 2025)
  • Z-2164-2025 Class I — Automated Impella Controller (AIC), used in left heart support blood pump, inclu (June 23, 2025)
  • Z-0829-2025 Class I — Impella RP with SmartAssist; Product Number: 0046-0035; (December 12, 2024)
  • Z-0830-2025 Class I — Impella RP Flex with SmartAssist; Product Number: 1000323; (December 12, 2024)
  • Z-2958-2024 Class II — Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; (August 5, 2024)