Medtronic Announces Voluntary Recall of Its Pipeline(TM) Embolization Device, Alligator(TM) Retrieval Device, X-Celerator(TM)...
October 14 2016 - 4:30PM
DUBLIN - Oct. 14, 2016 -
Medtronic plc (NYSE: MDT) today announced that it has notified
customers of a voluntary recall of certain lots of its Pipeline(TM)
embolization device, Alligator(TM) retrieval device and
X-Celerator(TM) hydrophilic guidewire. The recall also includes the
stylet containing UltraFlow(TM) flow directed micro catheters and
Marathon(TM) flow directed micro catheters. These products are
produced, marketed and sold by Medtronic's Neurovascular business,
which is part of the Brain Therapies division in the company's
Restorative Therapies Group.
This voluntary recall is being conducted due to
the potential separation and detachment of the
polytetrafluoroethylene (PTFE) coating on parts of these devices.
Should the PTFE separate from the delivery wire or stylets, PTFE
particulate could enter the blood stream of the patient. PTFE in
the blood stream, based on the size and quantity, could lead to a
thromboembolic event.
Medtronic initiated customer communication of the
recall by letter on October 5, 2016, and is requesting customers to
quarantine all affected product that remain in the inventory and
return to Medtronic. The U.S. Food and Drug Administration (FDA)
and other regulatory bodies also have been notified.
At the initiation of this recall, 84,278 units
potentially affected by this recall had been distributed worldwide.
The products were manufactured from July 2014 to September 2016.
Additional information about the recall, including the specific lot
numbers of affected product, can be found at
http://bit.ly/2dTvety.
Medtronic is taking this voluntary action as a
precaution and has received no reports of patient injuries to date
related to this issue. The full recalled product list of affected
lot totals is itemized below:
Product Name |
Number of Affected Lots |
Pipeline(TM) embolization device |
1742 |
Alligator(TM) retrieval device |
171 |
X-Celerator(TM) hydrophilic guidewires |
210 |
UltraFlow(TM) HPC flow directed micro catheters/
Marathon(TM) flow directed micro catheters |
1790 |
The Pipeline(TM) 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 first generation Pipeline(TM)
embolization device is affected by this action due to the PTFE
coated delivery wire, which is part of the disposable delivery
system (the braid implant is not affected). The second-generation
device, Pipeline(TM) Flex embolization device, is not affected by
this recall.
The Alligator(TM) retrieval device is intended for
use in the peripheral and neuro-vasculature for foreign body
retrieval. The X-Celerator(TM) hydrophilic guidewire is indicated
for general intravascular use to aid in the selective placement of
catheters in the peripheral, visceral and cerebral vasculature
during diagnostic and/or therapeutic procedures. The UltraFlow(TM)
flow directed micro catheter is designed for the subselective
infusion of physician-specified therapeutic agents such as
embolization materials and diagnostic materials such as contrast
media in tortuous, distal vessels. The Marathon(TM) Flow Directed
Micro Catheter is intended to access peripheral and neuro
vasculature for the controlled selective infusion of
physician-specified therapeutic agents such as embolization
materials and of diagnostic materials such as contrast.
Adverse reactions or quality problems experienced
with the use of these products may be reported to the FDA's
MedWatch Adverse Event Reporting program either online, by regular
mail or by fax:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax:
Download form www.fda.gov/MedWatch/getforms.htm or call
+1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax
to +1-800-FDA-0178.
For information or to report a problem, please
contact the Medtronic Lifeline Service at any time at
+1-877-526-7890.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 88,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
Contacts:
David Young
Public Relations
+1-508-452-1644
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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