Z-1394-2011

Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20

Name: Z-1394-2011 Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2010-09-28
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2010-09-28 / Terminated

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20 on 2010-09-28. The reason FDA records is "A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1394-2011
Status: Terminated
Initiated: 2010-09-28
Posted: 2011-02-22
Terminated: 2011-08-11
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: A wrong ball bearing was installed in the pump heads of product. This may make the pump head wear out and cease function.
FDA root cause: Component change control
Action: Maquet hand delivered a letter to the consignee on 10/4/2010.
Quantity in commerce: 4 units
Distribution: One hospital in New York City
Product codes and lots: Device Part Number (Model Number): 703309 Serial Numbers: 93202512, 93202514, 93202526, 93202527

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)