Abbott recalls MitraClip on faulty catheter fears

May 9, 2011 by MassDevice staff

Abbott Laboratories recalls its MitraClip system after one patient dies after surgery to remove a detached imaging ring.

Abbott

Abbott Laboratories (NYSE:ABT) recalled its MitraClip aortic valve repair device because part of a delivery catheter can fall off when the catheter is withdrawn.

One patient died after surgery to remove a ring designed to make the catheter visible to imaging equipment. The ring detached in three other cases as well, according to Abbott.

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The worldwide recall affects the U.S., where the system has yet to approved for anything beyond investigational uses, but doesn't involve the device itself.

"We're working on a minor modification to the delivery catheter and expect to resume shipments as soon as possible," Abbott spokesman Jonathon Hamilton told the Wall Street Journal.

The MitraClip is designed to correct the alignment of the leaves of leaky mitral valves in the heart, as an alternative to open heart surgery. It's early days yet for the device, which pulls down only $10 million to $20 million a quarter. That's a drop in the bucket compared with ABT's overall sales of more than $9 billion last quarter.

Abbott shares closed up a hair at $52.66.

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