Thoratec's ITC Division Receives FDA Warn... ( Matter Involves Certain Lo...)

Thoratec's ITC Division Receives FDA Warning Letter

Date:11/7/2007

Matter Involves Certain Lots of ProTime(R) Instruments

PLEASANTON, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, said today that its International Technidyne Corporation (ITC) division has received a Warning Letter from the U.S. Food and Drug Administration (FDA) stating concerns about ITC's quality systems and specifically related to certain production lots of its ProTime System anticoagulation monitoring device.

The company said the Warning Letter relates to manufacturing and quality control issues involving a component from an outside supplier that could cause specific lots of the system to deliver error messages on the display instead of test results and/or the remote possibility of incorrect readings of patient blood coagulation levels.

ITC is scheduled to meet with FDA to discuss the Warning Letter and ITC's responses and believes that part of its corrective action will involve a voluntary recall of certain lots of its ProTime system, involving approximately 5,800 of the devices. ITC is not aware of any patient-related issues related to this matter. The company said that it believes the issue has been addressed and should not affect any future ProTime System shipments.

Management estimated that the cost of the product recall will be in the range of $0.5 million to $1.0 million and accordingly indicated that the company believes that this matter will have no impact on the company's financial guidance for fiscal 2007.

Thoratec is a world leader in therapies to address advanced stage heart failure. The company's product lines include the Thoratec VAD(R) (Ventricular Assist Device) and He
'/>"/>

0

GOOD

Page: 1 2 3
Related medicine news :

1. HEI, Inc. Announces Sale of RFID Division Assets
2. QUANTEL Intends to Strengthen its Dermatology/ Aesthetics Division With the Acquisition of WaveLight Aesthetic GmbH
3. HEI, Inc. Closes on Sale of RFID Division Assets
4. Hooper Holmes Names Chris Behling President of Health & Wellness Division
5. Hooper Holmes Launches Health & Wellness Division at 2007 Disease Management Leadership Forum and Integrated Care Summit
6. Robert J. Heine, M.D., Ph.D., F.R.C.P. to Join Lilly; Distinguished Diabetes Expert to Lead Diabetes/Endocrine Medical Division
7. AHF Launches Public Health Division
8. Crdentias National Director of Travel Services Provides an Exclusive Interview on the Growth of Crdentias Travel Nurse Division
9. Global Med Technologies(R), Inc.s Division, Wyndgate Technologies(R), to Exhibit at 60th Annual AABB Conference
10. Dr. Stephen Paget, Physician-in-Chief and Chairman, Division of Rheumatology, at Hospital for Special Surgery is Available to Comment on a Recent CDC Study on the Impact of Arthritis in the Work Place
11. Bryan R. Rogers Appointed President of Far West Division

Post Your Comments:

Thoratec's ITC Division Receives FDA Warn...( Matter Involves Certain Lo...),Health