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) January 28, 2002
----------------
NOVOSTE CORPORATION
(Exact name of registrant as specified in its charter)
Florida 0-20727 59-2787476
- --------------------------------------------------------------------------------
(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification)
3890 Steve Reynolds Blvd., Norcross, GA 30093
---------------------------------------------------
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (770) 717-0904
--------------
(Former name or former address, if changed since last report)
Item 5. Other Events
On January 24, 2002, the Registrant initiated a voluntary recall of 50
Beta-Cath(TM) System transfer devices that had been distributed with incorrect
prescription labeling information. Recent tests conducted by the Registrant
demonstrated that the radioactive source trains included in the transfer devices
subject to the voluntary recall had been calibrated incorrectly at the
Registrant's manufacturing facility on December 20, 26 and 27, 2001. Based on
internal analysis and an independent assessment by a radiation oncologist and
medical physicist, the Registrant believes that the incorrectly calibrated
source trains cause no greater health risk than that which is generally present
within any vascular brachytherapy procedure.
The Registrant has notified the Food and Drug Administration of its intent to
recall the products and its plan for recall and corrective actions and has begun
notifying affected customers. Registrant believes that it will replace all
recalled products at customer facilities within fourteen (14) days and that the
corrective actions will resolve the incorrect calibration issues associated with
the voluntary recall.
The forward-looking statements included in this Report reflect management's best
judgment based on factors currently known. Actual results may differ materially
from those projected in these forward-looking statements based upon risks and
uncertainties, such as timing and receipt of regulatory approval of the proposed
recall plans, failure of corrective actions to remedy potential errors in
quality assurance or manufacturing operations, timing of customer compliance
with recall notifications and product availability for replacement of affected
product.
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.
Dated: January 28, 2002
NOVOSTE CORPORATION
-------------------
(Registrant)
By: /S/ EDWIN B. CORDELL, JR.
--------------------------
Edwin B. Cordell, Jr.
Vice President - Finance