280 results

• Surgical 3D Imaging Guide System Recalled Due to Software Problems That May Cause Brain Damage, Death

  December 3, 2018

  Russell Maas

  A class I recall of the BrightMatter Guide System, used to image the brain during brain surgery, warns that a software problem could result in severe injury or death.

• Medtronic Faces Investigations Worldwide Over Alleged Improper Conduct, Unsafe Medical Devices: “Implant Files” Report

  November 30, 2018

  Irvin Jackson

  A new report finds that Medtronic or its subsidiaries were responsible for one-fifth of all medical device recalls last year, and raises questions about the company's commitment to avoid unfair business practices which got it into trouble with the U.S. Justice Department in 2008.

• Roche To Replace All Warfarin CoaguChek Test Strips In The U.S.

  November 20, 2018

  Russell Maas

  Roche is telling consumers it will replace all recalled CoaguChek Test Strips used in the U.S. to check the effectiveness of warfarin and other blood thinners following a massive recall.

• CoaguChek Warfarin Test Strips Recalled Over Inaccurate Test Results

  November 6, 2018

  Russell Maas

  More than 1 million CoaguChek test strips used to check blood coagulation have been recalled due to inaccurate results, which can cause medication errors.

• Wearable Cardioverter–Defibrillators Failed To Reduce Risk Of Death For Recent Heart Attack Patients: Study

  October 4, 2018

  Irvin Jackson

  A new study suggests that wearble heart defibrillators do not increase the risk of survival in patients who recently suffered a heart attack.

• Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps Recall: Patient Injury Risk

  September 24, 2018

  Russell Maas

  A Marquet/Getinge intra-aortic balloon pump recall comes following revelations that the devices may not work properly at higher altitudes.

• FDA Issues Warning On Recalled CyPass Glaucoma Micro-Stents

  September 17, 2018

  Irvin Jackson

  The FDA has issued a warning about the risks of the CyPass Micro-Stent glaucoma implant following a recall issued late last month.

• FDA Approves High-Risk Heart Devices On Scant Scientific Evidence: Study

  September 5, 2018

  Martha Garcia

  A new study highlights concerns with the FDA's approval process for high-risk medical devices, pointing out more than a dozen times heart devices were recalled following approval over the last several years.

• CyPass Glaucoma Micro-Stent Recall Issued Over Safety Concerns

  September 4, 2018

  Irvin Jackson

  Safety concerns and potential vision loss have led to a CyPass Micro-Stent recall.

• Jaundice Meters Recalled After Misinterpretations Result In Severe Injuries

  June 25, 2018

  Russell Maas

  Following reports of displays being misinterpreted, some Draeger jaundice meters have been recalled due to potential misdiagnosis of jaundice in infants.