FDA Classifies Two Field Actions Related to HeartWare HVAD System as Class 1 Recalls
September 30 2016 - 9:00AM
DUBLIN - Sept. 30, 2016 -
Medtronic plc (NYSE:MDT) announced today that two previously
communicated global voluntary recalls related to the HeartWare
International (HeartWare) HVAD® System have been classified as
Class 1 by the U.S. Food and Drug Administration (FDA). Class 1
recalls describe situations where there is reasonable risk of
serious adverse health consequences or death.
In a safety notification letter distributed
globally in May and June 2016, HeartWare® notified physicians
regarding potential damage to controllers from exposure to moisture
through loose power and data connectors. In the U.S., all clinician
notifications have been acknowledged, and globally 99 percent of
clinician notifications have been acknowledged.
Hospital clinicians were advised to inspect
patients' HVAD HeartWare Controllers for loose connectors at
patients' regularly scheduled appointments and to replace affected
controllers with a new controller at the clinicians' discretion.
Clinicians also were advised to remind patients about the safe use
of the HVAD System, particularly with regard to moisture and proper
connection to power and data sources. Damage to the controllers
from this issue could cause loss of communication between the
controller and monitor, reduced ability to detect alarms or
interruption of circulatory support due to pump stop, which could
lead to serious injury or death.
HeartWare controllers subject to this safety
notification include the following models sold worldwide:
At the initiation of this recall, approximately
8,799 potentially affected HVAD HeartWare Controllers with these
model numbers had been distributed and remained in use by patients,
worldwide. As of Sept. 26, 2016, this recall and subsequent
inspection of patients' controllers has resulted in the replacement
of 308 affected HVAD controllers worldwide.
In August 2016, HeartWare issued a global
voluntary recall of certain models of unimplanted, sterile HVAD®
Pump Implant Kits (pumps) in hospital inventory. The HVAD pumps
contained in these sterile implant kits may be susceptible to
electrical faults and connection failures if fluid enters the
driveline-to-controller connector during or after the implant
procedure. Electrical faults or connection failures could interrupt
circulatory support due to a pump stop, potentially resulting in
serious injury or death. In the U.S., all clinician notifications
have been acknowledged, and globally 89 percent of clinician
notifications have been acknowledged.
Clinicians were advised to review hospital
inventories for HVAD implant kits (pumps) with serial numbers lower
than HW25838 with the following model number
and notify the company for replacement:
At the initiation of this recall, 350 potentially
affected HeartWare HVAD implant kits with these model numbers had
been distributed and remained in hospital inventories, worldwide.
As of Sept. 26, 2016, 323 of the 350 implant kits, or 92 percent,
have been used or returned to HeartWare.
Medtronic acquired HeartWare on Aug. 23, 2016; the
combined organization is committed to putting patient safety and
customers first and to implementing manufacturing enhancements to
address these issues.
The HVAD System includes a ventricular assist
device (VAD), or mechanical pump, that pumps blood to the body when
one of the heart's natural pumps (a ventricle) does not perform
well. The controller is a small computer that monitors the pump.
These implanted systems can allow people with advanced heart
failure to return to a fuller life while they await heart
transplantation.
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:
- 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
Clinicians with questions should contact their
HeartWare representative, call Medtronic HeartWare's 24-hour
Clinical Support line at (888) 494-6365 or email
FSCA@heartware.com.
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:
Chris Garland
Public Relations
+1-763-526-1621
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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