Abiomed, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2128-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

Product Classification:

Class II

Date Initiated: May 26, 2023

Date Posted: July 19, 2023

Recall Number: Z-2128-2023

Event ID: 92521

Reason for Recall:

There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.

Status: Ongoing

Product Quantity: 37 units

Code Information:

UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590

Distribution Pattern:

US Nationwide distribution in the states of MN, NJ, TN.

Voluntary or Mandated:

Voluntary: Firm initiated