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): June 4, 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
On June 4, 2014, HeartWare International, Inc. (Nasdaq: HTWR) announced that on June 3, 2014 it received a warning letter from the U.S. Food and Drug Administration (FDA) resulting from an inspection of the company’s operations, development and manufacturing facility in Miami Lakes, Florida, conducted in January 2014. A copy of the release is filed with this report as Exhibit 99.1 and is incorporated by reference into this Item 8.01.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No. | Description | |
| 99.1 | Press Release issued by HeartWare International, Inc. dated June 4, 2014. | |
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: June 4, 2014 | By: | /s/ Lawrence J. Knopf | ||
| Name: Lawrence J. Knopf | ||||
| Title: Senior Vice President, General Counsel and Secretary | ||||
INDEX TO EXHIBITS
Exhibit No. | Description | |
| 99.1 | Press Release issued by HeartWare International, Inc. dated June 4, 2014. | |