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:5/6/2015)... Anitha Nallari, MD has joined Shakir ... in Columbus, OH. Dr. Nallari will see patients with ... breast cancer, lung cancer, GI and gallbladder cancer, head and ... hematology. , Dr. Anitha Nallari is Board Certified ... Board of Internal Medicine. She completed her medical education in ...
(Date:5/6/2015)... (PRWEB) May 06, 2015 Follow ... sanitizers are increasing, driven by the rising consumer awareness ... spread of contagious diseases. Hand washing is becoming a ... consumer apprehension over contracting infections. Periodic outbreak of Avian ... recent Ebola virus disease (EVD) epidemic in ...
(Date:5/6/2015)... has opened press registration for TU-Automotive Detroit as the ... headlines of major publications world-wide. With 150+ speakers from ... to share their visions for the future of connected ... to go behind the scenes and hear major automakers’ ... year we’re releasing a preview of all the major ...
(Date:5/6/2015)... 2015 Dr. Vito C. Quatela, one of ... recently completed a medical mission trip to Hanoi, Vietnam with ... affected by microtia and other deformities of the face. , ... ended on April 26, Dr. Quatela and his team performed ... congenital deformity where the outside of the ear is underdeveloped. ...
(Date:5/6/2015)... The Florida Council on Compulsive Gambling, Inc. (FCCG), along ... Geriatric Education Center, Mental Health Association of Southeast Florida, ... Abuse, will hold its annual conference in Ft Lauderdale ... , This important event will address topics such as ... clinical training for problem gambling treatment services. “This ...
Breaking Medicine News(10 mins):Health News:New Oncologist to Join Hematology Oncology Consultants, Inc. 2Health News:New Oncologist to Join Hematology Oncology Consultants, Inc. 3Health News:Growing Apprehension Amid Disease Outbreaks Drives Global Sales of Hand Sanitizers, According to a New Report by Global Industry Analysts, Inc. 2Health News:Growing Apprehension Amid Disease Outbreaks Drives Global Sales of Hand Sanitizers, According to a New Report by Global Industry Analysts, Inc. 3Health News:Growing Apprehension Amid Disease Outbreaks Drives Global Sales of Hand Sanitizers, According to a New Report by Global Industry Analysts, Inc. 4Health News:Press Registration for TU-Automotive Detroit Now Open 2Health News:Dr. Vito Quatela Completes Successful 10-Day Medical Mission Trip to Hanoi, Vietnam 2Health News:Dr. Vito Quatela Completes Successful 10-Day Medical Mission Trip to Hanoi, Vietnam 3Health News:Conference on Problem Gambling to be held in Ft. Lauderdale, FL 2
... services company, explains the repercussions and risks of waiting to file for ... ... make the mistake of waiting too long to apply for Social Security ... of people in the Social Security Disability Insurance (SSDI) process ...
... SEIU announced today that,its California healthcare members have voted ... state,s long-term care workers. The International,Executive Board (IEB), ... of the non-binding advisory vote next month as it,considers ... workers. , "This ...
... of Eastern,Pennsylvania has begun overseeing and coordinating services ... of services to,Medicare beneficiaries. These services include ... providing,transportation to and from those appointments and providing ... Bravo Health. , ...
... statement from Peter H. Cressy, president of the Distilled Spirits ... The Distilled Spirits Council is pleased to see ... point out that these declines may reflect the greater decline ... drinking age. The research is clear that most youth who ...
... ... Boulder Creek, CA (PRWEB) December 11, 2008 -- Two ... taking care of their employees and have been rewarded for that ... has earned each the ,HeartMath Hospital, designation and the ,Continuity of ...
... for some creative stocking-,stuffer ideas to keep your family,s teeth clean and healthy ... Ohio and Indiana recommends the following gift,ideas to ensure healthy teeth and gums ... Toothbrushes, Musical toothbrushes play popular songs ... minutes. A musical toothbrush is a great way to make, ...
Cached Medicine News:Health News:Time is Money When People Wait Too Long to Apply for Social Security Disability Benefits 2Health News:Time is Money When People Wait Too Long to Apply for Social Security Disability Benefits 3Health News:Time is Money When People Wait Too Long to Apply for Social Security Disability Benefits 4Health News:California SEIU Members Support Single Union Uniting Long-Term Care Workers 2Health News:California SEIU Members Support Single Union Uniting Long-Term Care Workers 3Health News:Patient Care Means Employee Care at Illinois Hospitals 2Health News:Patient Care Means Employee Care at Illinois Hospitals 3Health News:Patient Care Means Employee Care at Illinois Hospitals 4Health News:Patient Care Means Employee Care at Illinois Hospitals 5Health News:Patient Care Means Employee Care at Illinois Hospitals 6
(Date:5/6/2015)... , May 05, 2015 Research and ... the addition of the "Chromatography (Instruments and ... report to their offering. Chromatography is ... identifying the component of a complex mixture by ... the decades the scientists have considered chromatography as ...
(Date:5/6/2015)... May 06, 2015 Research and Markets ... of the "Global Insulin Patch Market Opportunity ... Highly advanced technology like ultrasound and iontophoresis are ... patches. Depending upon the type of technique, their ... reach of several patients. In long-term, it would ...
(Date:5/6/2015)... , UAE, May 6, 2015 NVSSoft, ... solutions, has been named a "Cool Vendor" by top IT ... Emerging Markets 2015". Gartner defines a "Cool Vendor" ... innovative, impactful and intriguing. The report highlights that, ... organizations operate in emerging markets should look at local technologies ...
Breaking Medicine Technology:Global Chromatography (Instruments and Reagents) Market 2015 - Forecasts to 2019 2Global Insulin Patch Market Opportunity Analysis 2015 2UAE-Based Software Developer Named by Gartner as a Cool Vendor 2UAE-Based Software Developer Named by Gartner as a Cool Vendor 3UAE-Based Software Developer Named by Gartner as a Cool Vendor 4
... Stimulator is a portable, battery-powered bone growth stimulator ... The device is worn for 30 minutes each ... the fusion site. The device uses a unique ... low energy signal that is very potent in ...
... The Frontier device is ... device with one atrial and ... with chronic atrial fibrillation (AF) ... node ablation and who have ...
... incorporates new advances in CRT and ICD therapy. ... Platform. With this device, we offer: ... or less throughout the life of the device ... longevity over InSync II Marquis) , Separately programmable ...
Intrinsic Dual Chamber ICD With MVP Mode (Managed Ventricular Pacing). MVP promotes intrinsic conduction and is clinically proven to reduce unnecessary right ventricular (RV) pacing to approximately...
Medicine Products: