Navigation Links
Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA
Date:2/25/2010

es were made to correct this flaw, according to the information.

In early 2004, Guidant allegedly discovered a similar short-circuiting problem with its Renewal 1 and Renewal 2 devices. Following the July 2004 death of a patient associated with a shorted Renewal in Spain, the information charges that Guidant knew that the physician operating instructions for responding to a short-circuit within the device were false and misleading. In an effort to remedy this, Guidant sent a communication by overnight delivery to physicians which the company dubbed a "Product Update." The information alleges that this communication was actually a correction to the device which attempted to mitigate the safety risk posed by the short-circuiting. Guidant was required by law to alert FDA of this action within ten days. The information charges that Guidant failed to make that notification.

Guidant issued safety advisories on the Prizm 2 and Renewal devices in June 2005. FDA classified those advisories as "Class I" recalls, the most serious classification of recall, concluding that there was a reasonable probability that the affected devices could cause serious adverse health consequences or death.

"The government charges that Guidant committed serious crimes by undermi
'/>"/>

SOURCE U.S. Department of Justice
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. TriReme Medical, Inc. Receives FDA 510K Clearance for Glider(TM) PTA Balloon Catheter
2. Chinas leading electronic systems design event to highlight next-generation medical, automotive and green power technologies
3. Sanmina-SCI Tatabanya, Hungary Facility Achieves ISO 13485 Certification for Medical Devices
4. PointCare Donates Diagnostic Tests to Haitian Clinics to Ensure Resumption of Critical HIV/AIDS Patient Care and Bolster Emergency Medical Treatment for Earthquake Victims
5. Solta Medical to Participate in 2nd Annual Lazard Capital Markets Medical Technology Conference
6. Biomedical Advanced Research and Development Authority (BARDA) Project for Radiation Exposure Research Awarded to SRI International
7. Americans Living Longer, Healthier Lives Due to Medical Innovation and New Therapies
8. Varian Medical Systems Showcases Advanced Radiotherapy and Brachytherapy Products at ACRO 2010, February 25-27, Florida, Booth No. 34-35
9. Elsevier is Meeting Todays Medical Students Needs With Online, Mobile and Print Tools
10. Many Americans Enjoying Longer, Healthier Lives Due to Medical Innovation and New Therapies
11. SPO Medical Granted Innovative Baby Monitoring Patent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2015)... , April 27, 2015 NxStage Medical, Inc. ... products, today announced that Jeffrey H. Burbank , Chief ... Care Conference in Boston, MA on ... A webcast of the event will be made available ... About NxStage NxStage Medical, Inc. ...
(Date:4/27/2015)...   Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX ... for human disease, will release its first quarter 2015 ... financial markets close.  Lexicon management will hold a conference ... financial results for the first quarter 2015 at 5:00 ... The dial-in number for the conference call is 888-645-5785 ...
(Date:4/27/2015)... 27, 2015  CryoLife, Inc. (NYSE: CRY ), ... on cardiac and vascular surgery, announced today that it ... Food and Drug Administration ("FDA") verifying that the Company ... the warning letter it received from the FDA in ... re-inspection in March 2015 by the FDA at CryoLife,s ...
Breaking Medicine Technology:NxStage to Present at the 40th Annual Deutsche Bank Securities Health Care Conference 2Lexicon To Report First Quarter 2015 Financial Results On April 29, 2015 2CryoLife Announces Resolution of FDA Warning Letter 2
... the new screening guidelines announced by the National,Comprehensive Cancer ... will encourage those at high risk for lung cancer ... LCA President Laurie Fenton Ambrose said that lung ... all the other major cancers combined,until more at risk ...
... ILE ) announced today the completion of ... Study IT-A-008 investigating the Isolagen,Therapy(TM) for the treatment ... be administered at seven clinical sites across the ... Therapy could hold great promise for the,treatment of ...
Cached Medicine Technology:Lung Cancer Alliance Commends NCCN on Screening Guidelines 2Isolagen, Inc. Completes Enrollment in Isolagen Therapy(TM) Phase II/III Acne Scar Study 2Isolagen, Inc. Completes Enrollment in Isolagen Therapy(TM) Phase II/III Acne Scar Study 3
(Date:4/28/2015)... 2015 SeniorCare.com has published the ... reality problem Americans have regarding aging and long-term care ... care services as they age, 63% of Americans do ... In the report, Carol Marak of SeniorCare.com interviewed 44 ... Health Care Association and The Scan Foundation. The experts ...
(Date:4/28/2015)... FL (PRWEB) April 28, 2015 ... organization which provides vascular, electrocardiogram, echocardiogram, and NCV ... non-invasive vascular testing to help podiatrists diagnose peripheral ... challenging to diagnose PAD without the aid of ... Chief Medical Officer at Wimbledon Health Partners. ...
(Date:4/28/2015)... MO (PRWEB) April 28, 2015 The ... 2015 from 5:00 to 8:00 pm at the Sheraton Colonial ... than 50 hospitals, clinics and groups with career opportunities will ... represented. Attendees will enjoy free hors d’oeuvres and raffle prize ... PracticeMatch says “Boston is an ideal location to hold ...
(Date:4/28/2015)... (PRWEB) April 28, 2015 The Awareness Counselor ... the common topic of judging. According to Awareness Counselor, there ... people, when directed outward, and to an individual who self-judges. ... new clients as a class or one one one talk. ... founder of Awareness Counselor, is that every being on earth ...
(Date:4/28/2015)... Aliso Viejo, CA (PRWEB) April 28, 2015 ... created for use in Final Cut Pro X ... attention to specific areas on-screen with classic buttons, animated ... Annotate is the perfect compliment to vlogs, video series, ... Cut Pro X 10.2 or newer. ProTube Annotate ...
Breaking Medicine News(10 mins):Health News:SeniorCare.com Report: America Has a Major Misconception on Aging 2Health News:Podiatrists Affiliate with Wimbledon Health Partners to Diagnose Peripheral Arterial Disease 2Health News:PracticeMatch to Host Physician Career Fair at Sheraton Colonial Boston North Hotel on May 6, 2015 2Health News:PracticeMatch to Host Physician Career Fair at Sheraton Colonial Boston North Hotel on May 6, 2015 3Health News:What Happens When We Judge Ourselves and Others? – A New Concept Introduced 2Health News:What Happens When We Judge Ourselves and Others? – A New Concept Introduced 3Health News:FCPX plugin developer Pixel Film Studios releases Protube Annotate plugin for Final Cut Pro X. 2
... A Dartmouth-led study of young U.S. teens showed that ... items featuring an alcohol brand, and those who do ... drinking from susceptibility, to beginning drinking, to binge drinking, ... Archives of Pediatrics & Adolescent Medicine . , ...
... study finds , , TUESDAY, March 3 (HealthDay News) -- The ... the worse his sex life, a new study finds. , ... bypass surgery can help reverse those ills. , "Previous studies ... and can be associated with infertility, but we wanted to ...
... long-term investment and social responsibility in industry categoryMADISON, N.J., ... DGX ), the world,s leading provider of diagnostic testing, ... magazine,s list of the World,s Most Admired Companies. Quest ... "Pharmacy and Other Services." The 2009 ranking is the ...
... long-term care insurance. , ... Newark, NJ (PRWEB) March 3, 2009 -- ... you off, Prudential has a way out the maze. Prudential ... confuse the decision-making process., , , , ,Although its design is simpler, ...
... of the World,s Most Admired CompaniesEL SEGUNDO, Calif., March ... care services, today accepted the honor by FORTUNE ... facilities in the country. DaVita(R) ranked #1 in the ... Investment and Quality of Products and Services. Overall, the ...
... LITTLE FALLS, N.J., March 3 Cantel Medical Corp. (NYSE: ... discuss the Company,s results for its second quarter ended January ... Participating in the call will be Charles M. Diker, ... President and CFO; and Roy K. Malkin, President of Minntech ...
Cached Medicine News:Health News:Owning alcohol-branded merchandise associated with teen drinking behaviors 2Health News:Men's Sex Lives May Suffer as Waistlines Expand 2Health News:Quest Diagnostics Again Named to FORTUNE Magazine's 'World's Most Admired Companies' List 2Health News:Prudential Long-Term Care Product Simplifies Decisions 2Health News:Prudential Long-Term Care Product Simplifies Decisions 3Health News:FORTUNE Magazine Ranks DaVita #1 Health Care Medical Facility in Innovation, Investment and Quality 2Health News:Cantel Medical Corp. to Hold Conference Call to Discuss Results for Its Second Quarter Ended January 31, 2009 2
... is a fully automated, benchtop coagulation ... and immunological assays in true random ... of sample management offers high throughput ... without the need to interrupt current ...
The CA-50 is a compact semi-automated coagulation analyzerproviding 4-parameter random access....
... The ACL 100 is ... volume workloads, or as a ... also runs clotting assays, such ... Plus, it's backed by superior ...
... StatSite MHgb test system is ... dedicated hemoglobin test system designed ... public health clinics, blood centers ... portable system is designed for ...
Medicine Products: