Z-2140-2021Class II

Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers...

Name: Z-2140-2021 Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers...
Creator: Maquet Medical Systems USA
Published: 2021-07-14
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2021-07-14 / Terminated / root cause: design

FDA source

Maquet Medical Systems USA began a recall of Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extracorporeal... on 2021-07-14. 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-2140-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-14
Posted: 2021-07-23
Terminated: 2022-08-03
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: 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 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: On July 14, 2021, Maquet Getinge Group issued Urgent Medical Device Recall notices to customers via FedEx 2 day Delivery with Signature Proof of Delivery. Customers were advised to take the following action: - Users should take the unit out of operation at the earliest opportunity and decommission the unit. - MCP has not developed a cleaning protocol that meets current concerns and expectations of the FDA. - If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. - Please acknowledge receipt of the Urgent Medical Device Recall by completing and returning the response form. Please either fax the completed form to (866) 5715830 or send via email to [email protected].
Quantity in commerce: 33
Distribution: Distribution to US states of AL, CA, FL, IL, KS, MI, MO, NC, NE & OH.
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 70103.4653HCU 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-2140-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2140-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)