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.


Join the world's top medtech executives virtually for the leading event in medtech — The Virtual MedTech Conference by AdvaMed

Expect the same high-quality education, world-class speakers and valuable business development in a virtual format. Experience more of the conference with on demand content and partnering, as well as livestreamed sessions.

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

Spinal Elements, maker of a wide range of implants and products for minimally invasive spine procedures, has filed a $100 million IPO.

United Airlines will begin providing COVID-19 screening tests for passengers, allowing those who test negative to skip local quarantine requirements.

Babson Diagnostics has closed its series A funding round with a total of $13.7 million and named a new CEO.