CLASS II Device recall · Reported 27 Feb 2013 · FDA Enforcement Report

Maquet ELS Cannula recalled by Maquet Cardiovascular Us Sales

Maquet Cardiovascular Us Sales is recalling Maquet ELS Cannula, distributed in Arizona, Colorado, Florida, Tennessee, Texas. The recall was initiated on 26 Dec 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUS 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

Quantity recalled41 units - US Distirbution; 216 units - OUS Distribution

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0839-2013
FDA event ID: 64288
Recalling firm: Maquet Cardiovascular Us Sales, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 26 Dec 2012
FDA classified: 20 Feb 2013
Reported: 27 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

26 Dec 2012	Recall initiated by company
20 Feb 2013	Classified by FDA	+56 days
27 Feb 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.

Product as listed by the FDA

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

Where it was distributed

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.

Arizona Colorado Florida Tennessee Texas

Questions about this recall

Is Maquet ELS Cannula recalled?

Yes. Maquet Cardiovascular Us Sales recalled Maquet ELS Cannula on 26 Dec 2012. The recall is Class II and its status is Terminated. Recall number Z-0839-2013.

Why was it recalled?

ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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