UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the

Securities Exchange Act of 1934

Date of report (date of earliest event reported): July 30, 2014

 

 

HEARTWARE INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-34256   26-3636023

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

500 Old Connecticut Path

Framingham, MA 01701

(Address of principal executive offices)

Registrant’s telephone number, including area code:

508.739.0950

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 8.01 Other Events

As disclosed on May 1, 2014, HeartWare International, Inc. (Nasdaq: HTWR) issued a voluntary Urgent Medical Device Correction following an increase in reported power management complaints related to earlier-than-expected HeartWare® Ventricular Assist System battery depletion. On July 30, 2014, HeartWare expanded this field safety corrective action to include the voluntary recall of certain older batteries in serial number ranges BAT000001 to BAT039999 and BAT090000 to BAT099999, which are more likely to exhibit premature or unrecognized deterioration of battery capacity. The recall notice instructs clinicians to identify and replace batteries within this range from inventory and at each patient’s next regularly scheduled visit. We have initiated this action in Germany, where we have generally experienced a higher battery-related complaint rate than in the United States and the rest of Europe. Implementation of this voluntary recall in other countries, including in the United States, will follow after communication with relevant regulatory authorities. HeartWare recorded a $1.7 million charge for estimated costs in the second quarter of 2014 in connection with this voluntary recall.

Forward-Looking Statements

The release furnished with this report contains forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the commercialization and regulatory compliance of the HeartWare® Ventricular Assist System. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by federal securities laws and the rules and regulations of the Securities and Exchange Commission. HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation those described in Part I, Item 1A “Risk Factors” in HeartWare’s Annual Report on Form 10-K filed with the Securities and Exchange Commission. HeartWare may update risk factors from time to time in Part II, Item 1A “Risk Factors” in Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, or other filings with the Securities and Exchange Commission.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

      HeartWare International, Inc.
Date: July 31, 2014       By:  

/s/ Lawrence J. Knopf

        Name:   Lawrence J. Knopf
        Title:   Senior Vice President, General Counsel and Secretary