FRAMINGHAM, Mass., April 24, 2014 /PRNewswire/ -- HeartWare
International, Inc. (Nasdaq: HTWR) today announced issuance of a
clinician and patient reminder concerning the Urgent Medical Device
Correction distributed to all of its clinical sites by the company
in December 2013. The device correction discussed eight
complaints that the locking mechanism of the driveline connector of
the HeartWare® Ventricular Assist System had failed to
engage and instructed clinicians to inspect patient driveline
connectors. To ensure full awareness, the company is in the
process of redistributing this information to clinicians and
patients.
Impacted HeartWare Systems carry catalog numbers: 1100, 1101,
1102, 1103, 1104, and 1205 with serial numbers ranging from: HW001
to HW11270 and HW20001 to HW20296. All devices manufactured
since November 2013 incorporate
changes in manufacturing procedures which address this issue.
A disconnected driveline would result in a temporary pump stop
which could cause serious injury or death, depending on the
function of a patient's native heart. HeartWare issued the
December 2013 correction following
eight reported events in which the locking mechanism failed to
engage. Four of these eight cases resulted in a temporary
pump stop; however, none resulted in patient injury.
Patients are requested to discuss the correction notice with
their physician or VAD Coordinator. Clinicians are asked to inspect
the patient's driveline connector for proper locking at implant and
at each routine clinic visit to ensure that the connector assembly
remains secure. Should the locking mechanism fail to engage
or the driveline disconnects from the controller, the driveline
connector should be pushed back into the controller immediately.
Clinicians should promptly call their HeartWare
representative to arrange a permanent repair.
Patients with questions about this announcement should contact
their physician or VAD Coordinator at their hospital center.
Clinicians with questions related to this announcement or who wish
to schedule a driveline connector repair should contact HeartWare
Clinical Support at (888) 494-6365 or via email at
FSCA@heartware.com.
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
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, please
visit the Company's website at www.heartware.com.
Investor and media contact:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartwareinc.com
Phone: +1 508 739 0864
SOURCE HeartWare International, Inc.