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Posts Tagged ‘Articulating Single-Use Loading Units’

Covidien plc (COV) Conducts Voluntary Recall and Discontinues Duet TRS™ Reloa

Posted in Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Massachusetts Niche Suppliers and National Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, tagged , , , , on August 22, 2012| Leave a Comment »

Reporter: Aviva Lev-Ari, PhD, RN

Covidien plc (COV) Conducts Voluntary Recall and Discontinues Duet TRS™ Reloa

8/22/2012 8:00:30 AM

 

MANSFIELD, Mass.–(BUSINESS WIRE)– Covidien today announced that it is conducting a voluntary recall of all production lots for the Duet TRS™ Universal Straight and Articulating Single-Use Loading Units (SULU). In addition, the Company has discontinued manufacturing the Duet TRS Universal Straight and Articulating SULU.

 

Covidien has received one report that links the Duet TRS tissue reinforcement material to a post-operative injury after abdominal surgery. The Company has concluded that Duet TRS may have the potential to injure adjacent anatomical structures, which may result in life threatening post-operative complications. This voluntary recall is in addition to the recall announced January 16, 2012, relating to the contraindication of the device in the thoracic cavity. At that time, Covidien received reports of 13 serious injuries and 3 fatalities following the application of Duet TRS in the thoracic cavity.

The affected product codes and descriptions are as follows:

DUET4535 Duet TRS 45 3.5MM STRAIGHT SULU

DUET4535A Duet TRS 45 3.5MM ARTICULATING

SULU DUET4548 Duet TRS 45 4.8MM STRAIGHT SULU

DUET4548A Duet TRS 45 4.8MM ARTICULATING

SULU DUET6035 Duet TRS 60 3.5MM STRAIGHT SULU

DUET6035A Duet TRS 60 3.5MM ARTICULATING

SULU DUET6048 Duet TRS 60 4.8MM STRAIGHT SULU

DUET6048A Duet TRS 60 4.8MM ARTICULATING SULU

Launched in 2009, the Duet TRS reload is a SULU with a fully integrated tissue reinforcement system to support staple lines in tissues. To date, the Company has sold more than 540,000 units worldwide.

http://www.devicespace.com/news_story.aspx?NewsEntityId=270735

 

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