Z-0348-2017Class II

Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for...

Name: Z-0348-2017 Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2016-09-27
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2016-09-27 / Terminated / root cause: design

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers... on 2016-09-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0348-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-27
Posted: 2016-11-03
Terminated: 2019-08-19
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
Product code: DWC Controller, Temperature, Cardiopulmonary Bypass
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.
Root cause tag: design
FDA root cause: Device Design
Action: Maquet issued an Urgent Medical Device Recall letter/Return Response form dated September 27, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customer were instructed to complete the return response form via fax to 1-973-629-1518. For questions contact Maquet Customer Service at 1-888-627-8383 option 2 followed by option 2 Monday through Friday between 8 amd and 6 pm. EST.
Quantity in commerce: 305 units
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653 HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0348-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0348-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02

Product code DWC

K031544Class IIHeater Cooler Unit, Model Hcu 30Jostra AB / cleared 2003-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)