Coating issue that has dogged Medtronic’s Pipeline device sparks another recall

Dogged by problems with its plastic coating, Medtronic ($MDT) has issued another recall for its Pipeline device used to treat brain aneurysms.

Medtronic inherited the device, which is designed to divert blood from an aneurysm, in its $50 billion acquisition of Covidien. Pipeline was originally developed by Ev3, which Covidien bought in 2010, and got FDA approval in 2011.

The problem has dogged the device for several years. Back in 2014, Covidien issued a recall for Pipeline and its companion Alligator embolism retrieval device when reports began to surface that the plastic coating on the guidewire used to reduce friction could delaminate and detach.


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

The issue resurfaced and Medtronic issued another recall of Pipeline and Alligator devices as well as the X-Celerator hydrophilic guidewire and the UltraFlow and Marathon flow-directed microcatheters.

In all, about 84,000 units, made from July 2014 to September 2016, are included in the latest recall, the company said.

“Medtronic is taking this voluntary action as a precaution and has received no reports of patient injuries to date related to this issue,” the company said in a statement.

The Ireland-based devicemaker said, however, that its next-generation Pipeline Flex device isn’t affected by the recall. The FDA gave its regulatory okay to Pipeline Flex almost two years ago.

Suggested Articles

By employing heart rate signals, physical activity and sleep quality, common Fitbit trackers may be able to predict the spread of the flu.

Nanox has raised $26 million to help fuel the development and commercialization of its Star Trek-inspired digital X-ray bed.

Oncology is clearly a major medical and societal issue, but one that sees too much focus from biopharmas at the expense of other killers.