Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation Recalled by Maquet Cardiovascular Us Sales, Llc Due to ELS 15 Fr Cannula could potentially contain an...

Date: December 26, 2012
Company: Maquet Cardiovascular Us Sales, Llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Cardiovascular Us Sales, Llc directly.

Affected Products

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

Quantity: 41 units - US Distirbution; 216 units - OUS Distribution

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 5 states: AZ, CO, FL, TN, TX

Affected (5 states)Not affected

About Maquet Cardiovascular Us Sales, Llc

Maquet Cardiovascular Us Sales, Llc has 62 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report