Medtronic Issues Recall for Certain Neurovascular Products
October 14 2016 - 4:37PM
Dow Jones News
By Anne Steele
Medtronic PLC on Friday recalled certain lots of four of its
neurovascular products, saying they could put patients at risk for
blood clots.
The voluntary recall includes Metronic's Pipeline embolization
device, Alligator retrieval device and X-Celerator hydrophilic
guidewire as well as the stylet containing UltraFlow flow directed
micro catheters and Marathon flow directed micro catheters, all of
which are sold by Medtronic's neurovascular business.
The company said the polytetrafluoroethylene coating on parts of
the devices could potentially separate from the delivery wire or
stylets and enter the blood stream of the patient, which could lead
to a blood clot.
Medtronic said it began issuing recall letters Oct. 5 and is
asking customers to quarantine all affected product and return to
Medtronic. The U.S. Food and Drug Administration and other
regulatory bodies have been notified, the company said.
At the start of the recall, 84,278 potentially affected units
manufactured from July 2014 to last month had been distributed
world-wide.
Write to Anne Steele at Anne.Steele@wsj.com
(END) Dow Jones Newswires
October 14, 2016 17:22 ET (21:22 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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