282 results

• Cardiac Sciences Defibrillator Recall: Units May Fail When Needed

  February 11, 2010

  Staff Writers

  About 12,200 automated external defibrillators (AEDs) manufactured by Cardiac Science Corporation are being recalled because they may fail to deliver...

• Safesheath CSG Sheath Introducer Recall: Risk of Fracture

  February 10, 2010

  Staff Writers

  A Class 1 medical device recall has been issued for Safesheath CSG Sheath Introducer Systems by Thomas Medical Products, Inc. due...

• Becton Dickinson IV System Recall Issued After Patient Fatality

  February 10, 2010

  Staff Writers

  A medical device company is recalling 7.8 million catheters and intravenous (IV) fluid delivery system components after receiving reports of...

• Medtronic Sprint Fidelis Lead Failure Rates Reportedly As High As 9.2%

  February 8, 2010

  Staff Writers

  According to new research, the failure rate for recalled Medtronic Sprint Fidelis leads, which are small wires used to connect...

• FDA to Hold Public Hearings on Medical Device Approval Process

  February 1, 2010

  AboutLawsuits

  The FDA has scheduled a public meeting for late this month to review review the controversial process used to swiftly...

• Medtronic Sprint Fidelis Lead Failures Could Hit 30% in Four Years

  January 5, 2010

  AboutLawsuits

  A new analysis by UBS Investment Research warns that the failure rate for Medtronic Sprint Fidelis defibrillator leads could reach...

• Problems with FDA Medical Device Approval Process Identified in New Studies

  December 30, 2009

  AboutLawsuits

  Two new studies have been published that are highly critical of the way the FDA approves medical devices for human...

• Strkyer Operating Room Surgical System Recall: Software May Freeze

  November 27, 2009

  AboutLawsuits

  About two dozen Operating Room System II Surgical Navigation Systems distributed worldwide by Stryker Corporation have been recalled because the...

• Aortic Balloon Catheter Recall: May Rupture During Surgery

  November 11, 2009

  AboutLawsuits

  A Class I recall has been issued for Edwards Lifesciences CardioVations EndoClamp Aortic Catheters, which are used during heart bypass...

• Stryker Biotech Indicted for Fraudulent Promotion of Surgical Medical Devices

  October 29, 2009

  AboutLawsuits

  Stryker Biotech and its top management have been indicted by the U.S. Department of Justice (DOJ) on charges that they...