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:12/25/2014)... Overeating is common during the holidays, but there are strategies ... "Don,t arrive at a party hungry. It may seem ... attending a party, but deprivation leads to hunger, and hunger ... Hospital in Mount Kisco, N.Y., said in a hospital news ... and even to have a snack before attending a party ...
(Date:12/25/2014)... Thompson HealthDay Reporter WEDNESDAY, ... in on a "fountain of youth" drug that can delay ... adults, a new study suggests. Seniors received a significant ... targets a genetic signaling pathway linked to aging and immune ... The experimental medication, a version of the drug rapamycin, ...
(Date:12/25/2014)... (PRWEB) December 25, 2014 Thousands of ... move forward in a number of multidistrict litigations currently ... Virginia, Bernstein Liebhard LLP reports. According to an Order ... to convene a Joint Status Conference in all of ... Parties have been directed to submit a proposed agenda ...
(Date:12/25/2014)... 25, 2014 Plugin creators from Pixel ... A fully customizable business presentation tool made specifically for ... ProFire 5k business tool, users can now display their ... of Pixel Film Studios. “ProFire 5k gives users a ... add professionalism to a presentation” , Pixel Film Studios ...
(Date:12/25/2014)... Each year trauma accounts for approximately 42 ... across the nation (according to the Centers for ... Hospital Ambulatory Medical Care Survey collected data from ... They estimated that there were between 3.5 and 4.4 ... diagnosis of broken bone or fracture. , When ...
Breaking Medicine News(10 mins):Health News:Researchers Take 'First Baby Step' Toward Anti-Aging Drug 2Health News:Researchers Take 'First Baby Step' Toward Anti-Aging Drug 3Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 3Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 4Health News:Announcing a new ProFire 5k plugin from Pixel Film Studios for Final Cut Pro X Professionals 2Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 2Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 3Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 4
... (HealthDay News) -- More patients and families are using Facebook ... do improves the chances of obtaining a donor organ, a ... in Maywood, Ill., examined 91 Facebook pages that were seeking ... that 12 percent of the pages reported receiving a kidney ...
... Reporter , WEDNESDAY, May 30 (HealthDay News) -- The health ... but new research may add another condition to this list: ... lymph nodes in the groin area. Lymphedema in the ... removal of or damage to the lymph nodes. A blockage ...
... -- Advancements in human genetic research could lead ... protect against the misuse of people,s genetic data, the ... policy recommendations, including U.S. government oversight of genetic tests ... While discoveries in recent years -- such as the ...
... (HealthDay News) -- Scientists who were the first to fully ... step toward improving its yield, nutrition, disease resistance, taste and ... "Heinz 1706" tomato and found that it has about 35,000 ... the tomato -- whether it,s taste, natural pest resistance or ...
... , EVANSTON, Ill. --- American parents may want to ... their children from everyday germs. A new Northwestern ... evidence of chronic low-grade inflammation -- associated with diseases ... In contrast, about one-third of adults in the United ...
... busier than ever, but Case Western Reserve University psychologists ... fact, it appears to have increased. Psychologists ... when they analyzed 14 play studies that Russ conducted ... But as they report in "Changes in Children,s Play ...
Cached Medicine News:Health News:More Families Seek Kidney Donations on Facebook 2Health News:Obesity May Raise Odds for Painful Leg Condition 2Health News:Brave New World of Genetics Requires Safeguards, Experts Say 2Health News:Scientists Map the Tomato's Genome 2Health News:Understanding the links between inflammation and chronic disease 2Health News:Understanding the links between inflammation and chronic disease 3Health News:Despite less play, children's use of imagination increases over 2 decades 2
(Date:12/24/2014)... 2014  Medical Science Liaisons play a large role ... the medical device industry and key stakeholders, the role ... years as the device industry relies on them to ... by benchmarking firm, Best Practices, LLC, one area where ... is by harnessing new technology to enable education. Online ...
(Date:12/22/2014)... Mass. , Dec. 22, 2014 ... leading manufacturer of innovative dialysis products, announced today ... has cleared its System One™ to perform hemodialysis ... known as home nocturnal hemodialysis. NxStage,s® System One ... by the FDA for this indication. ...
(Date:12/22/2014)... , Dec. 22, 2014 Research and Markets ... of the "US Self-monitoring Blood Glucose Market" ... http://photos.prnewswire.com/prnh/20130307/600769 This market insight focuses on ... the United States . Reimbursement analysis ... Thorough product analyses for more than 73 SMBG meters ...
Breaking Medicine Technology:Role of Medical Science Liaisons Evolving in Medical Device Sector 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 3US Self-monitoring Blood Glucose Market 2
... The ABI Prism 7000 Sequence ... PCR system that detects and quantitates ... cycle-by-cycle detection of accumulated PCR product ... cycling, fluorescence detection, and application-specific software ...
RIA kit for the determination of autoantibodies to the TSH receptor (TSHR) in serum [with calibrators]....
ELISA kit for the determination of autoantibodies to the TSH receptor (TSHR) in serum....
Coated-Tube (CT) RIA kit for the determination of autoantibodies to the TSH receptor (TSHR) in serum...
Medicine Products: