Z-0839-2013Class II

Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of...

Name: Z-0839-2013 Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2012-12-26
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2012-12-26 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants on 2012-12-26. FDA classified it as Class II and gives the reason as "ELS 15 Fr Cannula could potentially contain an occluded arterial lumen". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0839-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-26
Posted: 2013-02-20
Terminated: 2014-05-08
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Maquet sent Urgent Device Recall Letters/Recall Acknowledgement Forms to their customers on 12/26/2012.
Quantity in commerce: 41 units - US Distirbution; 216 units - OUS Distribution
Distribution: Worldwide Distribution-USA including the states of AZ, CO, FL, TN, and TX and the countries of Australia, Canada, Czech Republic, Dubai/Bahrain/Kuwait/Lebanon/Saudi Arabia/Yemen, France, Germany, Hong Kong, Italy, Japan, Netherlands, Singapore, South Africa, Sweden, Switzerland, Thailand, Turkey, and UK.
Product codes and lots: US Distribution Part number 701017471 Lot numbers 92046825 92065723 92076940 OUS Distribution Part Number Lot Numbers 701002797 92050616 701002797 92052823 701002797 92052913 701002797 92058153 701002797 92063518 701002797 92068260 701002797 92069267 701002797 92072177 701002797 92075413 701002797 92077862 701005092 92081862 701005092 92049129 701005092 92070554 701005093 92049130 701005093 92056899 701005093 92065588 701005093 92069429 701005093 92070553 701005093 92071852 701005093 92073598 701005093 92076875 701017471 92076940 701046644 92063587 701050978 92047882 701050978 92053930 701050978 92054156 701050978 92056171 701050978 92056804 701050978 92065094 701050978 92067382 701050978 92068224 701050978 92069286 701050978 92071806

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0839-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0839-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20

Product code DWF

K002857Class IIEls Cannula (Kit), Model M1210-88,M1510-88Jostra AG / cleared 2000-10-05

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)