Framingham, Mass. — 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.
Consumer Contact: (888) 494-6365
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.
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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 [email protected].
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.
