Navigation Links
URGENT Thoratec Corporation Worldwide Recall of Implantable Ventricular Assist Device
Date:11/8/2007

PLEASANTON, Calif., Nov. 8 /PRNewswire-FirstCall/ -- Thoratec Corporation initiated a worldwide recall on October 19, 2007 involving all Implantable Ventricular Assist Devices (IVAD) having Catalogue No. 10012-2555-001, serial numbers 488 or higher and manufactured and distributed since October 2004. The current Instructions for Use state that IVADs may be implanted in the pre-peritoneal (internal) position or placed in the paracorporeal (external) position. In the paracorporeal position, the pneumatic driveline is entirely external to the patient and may be damaged if the driveline is bent at a sharp angle relative to its junction with the pump housing which could cause a reduction or interruption of circulatory support, potentially resulting in serious injury or death.

The affected IVADs were distributed directly to 87 hospitals throughout the United States and other countries. They can be identified by the serial number located both on the label of the sterile package and on the Y-connector at the end of the IVAD percutaneous driveline.

The firm voluntarily issued an Urgent Medical Device Correction notice with new instructions regarding placement and care of the IVAD driveline after learning of pneumatic leaks associated with certain surgical orientations of the pump when used in the paracorporeal position. In one incident a death resulted when a damaged driveline severed at its connection to the pump. Drivelines may be damaged when the driveline connection to the pump impinges on the patient's leg when the patient is in the sitting position. This may cause excessive stress on the driveline, resulting in damage and pneumatic leaks. FDA has been apprised of this action. This action does not affect IVADs implanted in the pre-peritoneal or other internal positions.

Thoratec has received seven reports of damaged drivelines in paracorporeal IVADs, five of which resulted in patient injuries and one in a patient death. These seven reports come
'/>"/>

SOURCE Thoratec Corporation
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. Health IT Now! Coalition to Discuss the Urgent Need to Pass Health IT Legislation
2. Americans consider global warming an urgent threat, according to poll
3. Thoratec Schedules Third Quarter Conference Call, Webcast
4. Thoratecs ITC Division Receives FDA Warning Letter
5. The ScottCare Corporation Completes Acquisition of Rozinn Electronics, a Leading Manufacturer of Cardiac Diagnostic Products
6. Brooke Franchise Corporation Announces Selected July Results
7. MedThink Communications Retained by NanoBio Corporation
8. EaglePicher Corporation Completes Transaction to Sell EaglePicher Boron, LLC to Ceradyne, Inc. for $69 Million
9. Dana Corporation, Inc. Enters Into Settlement Agreement With Dana Retiree Committee
10. Memry Corporation Announces Fiscal Fourth Quarter and 2007 Year End Earnings Release and Conference Call
11. Somanetics Corporation to Release Third Quarter 2007 Financial Results and Host Conference Call September 19
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/31/2015)... (PRWEB) March 31, 2015 Williams ... a repair visit when their home comfort is ... and make the visit fit into the customer’s ... provide fast, quality repair at requested times. ... and commercial customers in the Indianapolis area can ...
(Date:3/31/2015)... 2015 Tickets are now on sale ... tradition since 1973. The 2015 Spring production, Fairy Tales ... Ice. On April 24 in partnership with the Alzheimer's ... night tribute to the Pat Bowlen family, long-time partners ... the opening event proceeds will go to the Alzheimer's ...
(Date:3/31/2015)... Fitbody Personal Training LLC invites participants to get ready for ... workouts away from the gym and prepare to energize the ... LLC. The classes are moving outdoors. , Personal trainer ... outdoors on Thursday evenings starting April 2, 2015 and ending ... starts on April 11th and ends on May 16, 2015. ...
(Date:3/31/2015)... QMedET Solutions, LLC, is now ... industry’s most advanced speech recognition technology to another ... now experience the full benefits of a speech-enabled ... support services that ensure successful integration with leading ... proud to provide Dragon Medical Practice Edition 2 ...
(Date:3/31/2015)... (PRWEB) March 31, 2015 The Oliver ... page in response to client requests after Zofran ... that Zofran manufacturer, GlaxoSmithKline (GSK) failed to warn physicians ... associated with the medication and “illegally and fraudently” promoted ... women without receiving approval for that use from the ...
Breaking Medicine News(10 mins):Health News:Williams Comfort Air Launches Online Scheduling Tool to Indianapolis-Area Home and Business Owners 2Health News:FitBody Personal Training LLC Announces its Personal Training Classes are Moving Outdoors 2Health News:QMedET Solutions Announces Addition of Dragon® Medical Practice Edition 2 to its Roster of Products 2Health News:Zofran Lawsuit Information Page Launched In Response To Clients Request For Information On Potential For Zofran Birth Defects, The Olive Law Group 2Health News:Zofran Lawsuit Information Page Launched In Response To Clients Request For Information On Potential For Zofran Birth Defects, The Olive Law Group 3
... According to researchers at Hopkins University, they have found a ... in the immune system, surpassing an obstacle to certain ... from improving the body's immune response to developing cancer vaccines ... cells form the core of the blood system.// They can ...
... micro capsule coated with silicon, which could save the ... absorbing nutrients from the body //and stimulates the ... than onece a day to maintain their blood sugar ... Desai of the University of Illinois at Chicago Ms ...
... leading cause of disability in the United States, affects ... advances in treatment options and educational efforts,// depression has ... US. In fact, a recent study stressed that as ... fail to receive adequate treatment. ,Americans have ...
... the greatest increase in bone mineral after the growth spurt ... are in danger of suffering broken bones in later life,// ... skeleton during a vital two-year window before puberty, which is ... be between 10 and 12 and in boys it is ...
... electromagnetic fields (EMF) at home could double the risk ... //The three-year review was carried out for the International ... epidemiologists from major institutions around the world. ,Leukemia, ... third of all childhood cancers - around the world ...
... common learning disorder, affects nearly one in 24 people. ... read, write and spell. Dyslexia was found to have ... of the brain that controls movement, co-ordination and balance, ... led by Professor Roderick Nicolson, compared the brain activity ...
Cached Medicine News:Health News:A new study surpasses Gene Therapy Hurdle 2
(Date:3/31/2015)... , March 31, 2015 The Medical ... featured in the American Medical Group Association,s "High ... AMGA,s "High Performing Health" production is ... facing the nation,s healthcare system in delivering better ... profiled along with other leading organizations in the ...
(Date:3/31/2015)... March 31, 2015 According ... and Chemical Instrumentation Market (Chromatography, Electrophoresis, DNA Sequencer, PCR, ... Incubator, Fume Hood, Centrifuge) - Global Forecast to ... and Chemical Instrumentation Market is expected to reach ... from 2014 to 2019. Browse ...
(Date:3/31/2015)... March 31, 2015 Ryan & Maniskas, ... of directors of Hyperion Therapeutics, Inc. ("Hyperion" or the ... fiduciary duty and other violations of law related to ... Pharma plc in a transaction valued at approximately $1.1 ... and would like to learn more about this class ...
Breaking Medicine Technology:AMGA's High Performing Health News Program Features The Medical Letter 2Life Science and Chemical Instrumentation Market Worth $48.84 Billion by 2019 2Life Science and Chemical Instrumentation Market Worth $48.84 Billion by 2019 3Life Science and Chemical Instrumentation Market Worth $48.84 Billion by 2019 4Life Science and Chemical Instrumentation Market Worth $48.84 Billion by 2019 5Ryan & Maniskas, LLP Announces Investigation of Hyperion Therapeutics, Inc. 2
... patients with acute coronary syndrome being managed with ... ... TOKYO and INDIANAPOLIS, Feb. 21 Daiichi,Sankyo Company, Limited (TSE: 4568) ... the U.S. Food and Drug Administration (FDA) accepted,and designated Priority Review ...
... 21 MonoSol Rx, a drug delivery,company specializing ... it has successfully completed a pilot clinical study ... 5-HT3 receptor antagonist,used in the prevention and treatment ... film formulation of ondansetron was studied against,GlaxoSmithKline,s Zofran ...
Cached Medicine Technology:FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel 2FDA Grants Priority Review for Daiichi Sankyo, Lilly Drug, prasugrel 3MonoSol Rx Completes Thin Film Ondansetron Pilot Bioequivalence Study 2MonoSol Rx Completes Thin Film Ondansetron Pilot Bioequivalence Study 3
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
Medicine Products: