Z-3057-2011

Maquet HL Console for Heart Lung Machine HL20: HL 20 4-pumps console base: P/N 917741 HL 20 5-pumps console...

Name: Z-3057-2011 Maquet HL Console for Heart Lung Machine HL20: HL 20 4-pumps console base: P/N 917741 HL 20 5-pumps console...
Creator: Maquet Inc.
Published: 2011-06-20
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2011-06-20 / Terminated / root cause: design

FDA source

Maquet Inc. began a recall of Maquet HL Console for Heart Lung Machine HL20: HL 20 4-pumps console base: P/N 917741 HL 20 5-pumps console base: P/N 917751 The HL 20 is indicated for use as... on 2011-06-20. The reason FDA records is "HL 20 Consoles for 4-pump and 5-pump configuration can malfunction if an excessive amount of liquid is used causing circuit board malfunction". 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-3057-2011
Status: Terminated
Initiated: 2011-06-20
Posted: 2011-08-22
Terminated: 2012-10-16
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet HL Console for Heart Lung Machine HL20: HL 20 4-pumps console base: P/N 917741 HL 20 5-pumps console base: P/N 917751 The HL 20 is indicated for use as an extracorporeal circulation device for perfusion lasting not more then six hours. The HL console is equipped with a rack for accommodating the system's electronic modules.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: HL 20 Consoles for 4-pump and 5-pump configuration can malfunction if an excessive amount of liquid is used causing circuit board malfunction.
Root cause tag: design
FDA root cause: Device Design
Action: Maquet sent an URGENT PRODUCT RECALL NOTIFICATION letter dated June 17, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to acknowledge receipt of the notification by completing and sending back the attached response form whether or not they have any affected product, fax to 973-807-9210 no later than June 30, 2011. For any questions customers were instructed to contact thier local MAQUET representative.
Quantity in commerce: 229 units
Distribution: Nationwide Distribution
Product codes and lots: 510K numer K943803 Device Listing #E614811 HL-20 Console

Product code DTQ

K943803Class IIJostra Hl-20 Integrated Perfusion SystemJanus Biomedical, Inc. / cleared 1996-01-30

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)