DUBLIN, Ireland--(BUSINESS WIRE)--Apr. 11, 2014--
Covidien plc today announced that it has notified customers of a
voluntary recall to address an issue with certain lots of its Pipeline™
Embolization Device and Alligator™ Retrieval Device where the
polytetrafluoroethylene (PTFE) coating applied to the delivery wire
could delaminate and detach from the devices.
PTFE coating is used to reduce friction between devices and ease
navigation through the vasculature. Delamination of the PTFE coating
could potentially lead to embolic occlusion in the cerebral vasculature
with the risk of stroke and/or death.
Covidien learned of this issue through internal product testing. The
company has not received any reports of patient injuries to date related
to this issue.
The Pipeline™ Embolization Device is indicated for the endovascular
treatment of adults (22 years of age and older) with large or giant
wide‐necked intracranial aneurysms in the internal carotid artery from
the petrous to the superior hypophyseal segments. The Alligator
Retrieval Device is intended for use in the peripheral and
neuro‐vasculature for foreign body retrieval.
A total of 32 Pipeline Embolization Devices and 621 Alligator Retrieval
Devices are affected by this recall. The products were manufactured and
distributed from May 2013 to March 2014. This issue involves both the
Pipeline Embolization Device sold in the U.S., Australia, France,
Germany and United Kingdom, and the Alligator Retrieval Device, which is
sold in the U.S., Australia, Canada, Europe and Latin America.
Covidien alerted customers to the recall by letter on April 1, 2014, and
is arranging for replacement of the recalled products. The U.S. Food and
Drug Administration (FDA) and other regulatory bodies also have been
Adverse reactions or quality problems experienced with the use of this
product may be reported to the FDA’s MedWatch Adverse Event Reporting
program either online, by regular mail or by fax:
For information or to report a problem, please contact Covidien Customer
Service at 1-800-716-6700 between the hours of 7 a.m. and 7 p.m.
(central) or email CustomerServiceUS@Covidien.com.
The recall is expected to have a slight negative effect on sales and
earnings in the second half of fiscal 2014. However, the total impact
may increase depending on the timing of replacing the recalled products.
Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers
value through clinical leadership and excellence. Covidien develops,
manufactures and sells a diverse range of industry-leading medical
device and supply products. With 2013 revenue of $10.2 billion, Covidien
has more than 38,000 employees worldwide in more than 70 countries, and
its products are sold in over 150 countries. Please visit www.covidien.com
to learn more about our business.
Source: Covidien plc
Vice President, Communications
Vice President, External Communications