Abiomed, Inc.: Medical Device Recall in 2026 - (Recall #: Z-1469-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Impella RP with SmartAssist. Product Code: 0046-0035.

Product Classification:

Class I

Date Initiated: January 27, 2026

Date Posted: March 11, 2026

Recall Number: Z-1469-2026

Event ID: 98276

Reason for Recall:

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

Status: Ongoing

Product Quantity: 291 units

Code Information:

Product Code: 0046-0035. UDI-DI: 00813502011869.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated