65 results

• Medtronic Heart Implants Recalled Over Failure To Deliver Life-Saving Shocks

  February 27, 2018

  Irvin Jackson

  Medtronic is recalling a number of ICD and CRT-D heart implants due to a defect which could prevent them from providing life-saving shocks to patients.

• HeartStart MRx Defibrillator Recall Issued Due to Failure Risk

  February 12, 2018

  Russell Maas

  A HeartStart MRx Defibrillator recall has been announced due to defects which could result in the devices failing to give life-saving electrical shocks when needed.

• Zoll LifeVest 4000 Wearable Cardioverter Defibrillator Recall Issued Over Device Failures

  January 18, 2018

  Russell Maas

  Tens of thousands of Zoll LifeVest 4000 wearable defibrillators are being recalled due to an error which can prevent them from giving life-saving shocks.

• St. Jude Defibrillator Battery Failure Recall Updated To Announce New Battery Monitoring Software

  October 26, 2017

  Irvin Jackson

  The FDA has announced that St. Jude has released new software meant to provide earlier warning of possible battery failure in recalled defibrillator implants.

• St. Jude Defibrillator Battery Class Action Lawsuit Filed Over Delay in Announcing Recall

  September 25, 2017

  Irvin Jackson

  A class action lawsuit against St. Jude and Abbott Laboratories accuses the companies of knowingly selling defective defibrillators with batteries that could rapidly fail, costing insurers millions of dollars.

• Recalled St. Jude Defibrillators With Bad Batteries Continued to be Implanted in Patients: FDA

  April 19, 2017

  Irvin Jackson

  The FDA has issued a warning letter to St. Jude and its parent company, Abbott, indicating that they continued to ship out defective defibrillators after an October 2016 recall, resulting in seven patients being implanted with devices with batteries that could suddenly fail.

• Phillips HeartStart Rx Defibrillator Recall Issued Over Electrical Problems

  March 27, 2017

  Martha Garcia

  The FDA has issued a Class I recall notice for the HeartStart Rx Defibrillator, warning that electrical problems could cause the device to fail to deliver life-saving shocks.

• LIFEPAK 1000 Defibrillators May Shut Down During Use, FDA Warns

  March 9, 2017

  Russell Maas

  Problems with the LIFEPAK 1000 defibrillator could cause a failure to deliver life-saving shocks, resulting in an FDA Class I recall classification.

• Medical Device Cybersecurity Deficiencies Pose Wide Ranging Threats, RSA Conference Told

  February 27, 2017

  Irvin Jackson

  Medical devices and hospitals are dangerously vulnerable to cybersecurity breaches, according to a presentation at a recent cybersecurity conference.

• St. Jude Recalls Fortify, Unify, Assura ICDs and CRT-Ds Due to Rapid Battery Failure Risk

  October 26, 2016

  Irvin Jackson

  A warning over battery failures in some St. Jude ICD and CRT-D heart implants has been upgraded to a class I recall, the FDA's most serious recall classification.