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HeartWare Issues Reminder To December 2013 Driveline Connector Device Correction

    HeartWare Issues Reminder To December 2013 Driveline Connector Device
                                  Correction

PR Newswire

FRAMINGHAM, Mass., April 24, 2014

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.

  oComplete and submit the report Online: www.fda.gov/medwatch/report.htm
  oRegular 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.

Website: http://www.heartware.com
 
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