Mc3 Inc: Medical Device Recall in 2024 - (Recall #: Z-1310-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E

Product Classification:

Class II

Date Initiated: October 11, 2023

Date Posted: March 27, 2024

Recall Number: Z-1310-2024

Event ID: 94016

Reason for Recall:

May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer

Status: Ongoing

Product Quantity: 188 units

Code Information:

GTIN:(1)10854916006871; (2)10854916006895 All Serial Numbers between 481022923 and 481024039

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated