Maquet Medical Systems USA: Medical Device Recall in 2023 - (Recall #: Z-0290-2024)

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:

Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)

Product Classification:

Class II

Date Initiated: October 12, 2023
Date Posted: November 15, 2023
Recall Number: Z-0290-2024
Event ID: 93013
Reason for Recall:

It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.

Status: Ongoing
Product Quantity: 1022 units
Code Information:

UDI-DI: 04058863074863; Serial Numbers: 90414355 through 90414868

Distribution Pattern:

US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated