FRAMINGHAM, Mass., Feb. 20, 2015 /PRNewswire/ -- HeartWare
International, Inc. (Nasdaq: HTWR), is issuing a voluntary Urgent
Medical Device Recall in the United
States related to older HeartWare® Ventricular
Assist System Controllers, which were distributed in the U.S.
during the clinical trial period prior to Food and Drug
Administration (FDA) approval in 2012. HeartWare has
commenced this field action in other countries in recent weeks.
In letters to clinicians and patients, the company advises
that affected clinical trial controllers exhibit a higher
susceptibility to electrostatic discharge (ESD) than newer,
commercial controllers. An ESD event could result in a pump
stop, which could cause serious injury or death. Since
HeartWare has made design enhancements to the newer, commercial
controllers to improve immunity to ESD, this recall does not affect
newer, commercial controllers.
This recall of HeartWare controllers (product codes 1400 and
1401XX) distributed during the ADVANCE and ENDURANCE clinical trial
periods with Serial Numbers CON000001 through CON005472 is an
expansion of HeartWare's voluntary Field Safety Corrective Action,
FSCA APR2013. HeartWare estimates the recall will impact
approximately 120 patients in the U.S.
As part of the 2013 Notice, HeartWare provided information to
assist clinicians and patients in monitoring controller performance
and reducing the potential for an ESD event, which is a known risk
for electronic equipment. As stated in the 2013 Notice, patients
can reduce the risk of ESD by avoiding dry environments, certain
fabrics and materials such as silk clothing and carpeting,
electronic devices prone to static electricity and certain
activities such as vacuuming and removing clothes from a dryer.
Since the 2013 Notice, HeartWare has received reports of one
additional death and one additional serious injury in which ESD may
have caused or contributed to a pump stop.
Clinicians are being asked to identify patients with recalled
controllers, review the applicable risks with the patient and, if
medically advisable, exchange the recalled controllers under
medical supervision with a new controller (serial number CON005473
or higher). It is the treating physician's responsibility to
assess a patient's status and determine if the related risks are
acceptable. Patients should not attempt to exchange recalled
controllers, as controller exchanges may not be suitable for all
patients. It is recommended that exchanges of recalled
controllers be performed in a controlled setting under medical
supervision.
Patients with questions about this announcement should contact
their physician or VAD Coordinator at their hospital center.
Clinicians who wish to return affected product or with questions
should contact their HeartWare representative, call HeartWare's
24-hour Clinical Support line at (888) 494-6365 or email
FSCA@heartware.com.
HeartWare has advised FDA of this action. Adverse
reactions or quality problems experienced with the use of this
product may be reported to 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 the form to the address
on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
About HeartWare International
HeartWare International
develops and manufactures miniaturized implantable heart pumps, or
ventricular assist devices, to treat patients suffering from
advanced heart failure. For additional information, visit the
company's website at www.heartware.com.
Investor and media contact:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartware.com
Phone: +1 508 739 0864
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visit:http://www.prnewswire.com/news-releases/heartware-international-recalls-certain-older-heartware-clinical-trial-controllers-300039162.html
SOURCE HeartWare International, Inc.