Maquet Medical Systems USA: Medical Device Recall in 2021 - (Recall #: Z-2140-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal circulation and for blankets with which patients can be warmed or cooled.

Product Classification:

Class II

Date Initiated: July 14, 2021

Date Posted: August 4, 2021

Recall Number: Z-2140-2021

Event ID: 88285

Reason for Recall:

There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.

Status: Terminated

Product Quantity: 33

Code Information:

HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected.

Distribution Pattern:

Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.

Voluntary or Mandated:

Voluntary: Firm initiated