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.

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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.

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