66 results

• HeartMate II and HeartMate 3 LVAS Recall Follows 14 Deaths, Hundreds of Injuries

  April 16, 2024

  Russell Maas

  Nearly 14,000 Heart HeartMate II and HeartMate 3 LVAS devices are being recalled due to the risk of potentially lethal blockages that have already led to more than a dozen deaths.

• FDA Warns Doctors of Abbott Trifecta Valve Deterioration Risks

  February 28, 2023

  Russell Maas

  The FDA warns that Abbott Trifecta heart valve implants may deteriorate within only a few years, leading to the need for valve replacement and increasing the risk of patient death.

• Senator Questions Abbott for Covering Up Infant Formula Cronobacter Problems With Aggressive Legal Tactics

  October 14, 2022

  Irvin Jackson

  A letter by Senator Elizabeth Warren accuses Abbott Laboratories of hiding previous infant formula cronobacter problems through aggressive legal tactics.

• Abbott MitraClip Warning Issued By FDA Over Clip Lock Malfunctions

  September 9, 2022

  Martha Garcia

  The FDA warns that MitraClip heart valve repair devices may malfunction, resulting in a backflow of blood into the heart.

• FDA Warns Parents Not To Use “Mother’s Touch Formula”, Due to Lack of Nutrients For Infants

  September 8, 2022

  Russell Maas

  The FDA is calling on parents not to feed Mother's Touch formula to infants, due to a lack of proper nutrients and a possible infection risk.

• Complications with Left Atrial Appendage Occlusion (LAAO) Devices More Likely Among Women Than Men, FDA Warns

  September 28, 2021

  Russell Maas

  The FDA is warning that a form of heart surgery used to treat atrial fibrillation appears to carry greater health risks for women than men.

• Bioresorbable Vascular Scaffold Linked To Increased Risk of Blood Clots, Study Warns

  March 31, 2017

  Irvin Jackson

  A new study suggests that a type of heart implant being investigated by the FDA is linked to an increased risk of blood clots.

• FDA Investigates Abbott Absorb GT1 Bioresorbable Vascular Scaffold (BVS) Over Heart Problems

  March 20, 2017

  Irvin Jackson

  The FDA is warning about a risk of heart problems, such as heart attacks and deaths, associated with Abbott's BVS dissolving heart implant.

• MitraClip Heart Surgery Device Recall Issued After Patient Death

  March 16, 2016

  Russell Maas

  Thousands of MitraClip heart surgery devices have been recalled following one patient death and a number of injuries caused by part of the device being left in the heart.

• Acclaim Infusion Pump Recall Issued Due to Potentially Fatal Delays

  May 5, 2014

  Irvin Jackson

  The FDA warns that recalled Acclaim infusion pumps may cause overdoses or delay crucial medication therapy.