The Recall Desk
HighFDA (Devices)·Z-0839-2013·Announced 2013-02-27

Maquet ELS Cannula Recalled for Potential Arterial Lumen Occlusion

Maquet is recalling ELS 15 FR Cannulas used for infant ECMO because they may contain an occluded arterial lumen.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential occlusion in a critical life-support device for infants. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling the Maquet ELS Cannula 15 FR. This medical device is used for extracorporeal membrane oxygenation (ECMO) to treat respiratory insufficiency in infants.

The recall was initiated because the cannulas could potentially contain an occluded arterial lumen. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

The recall affects 41 units distributed in the United States and 216 units distributed outside the US. The affected products were distributed worldwide, including in the US states of Arizona, Colorado, Florida, Tennessee, and Texas, as well as in numerous international locations. Healthcare providers and consumers should stop using the affected units and contact the manufacturer for instructions.

The recalled product

Product
Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — ECMO Cannula
Hazard

Distribution

Distributed in 5 states:

Related recalls

Same manufacturer · Maquet Cardiovascular Us Sales, Llc

See all →