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.…
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.…
Problems with the LIFEPAK 1000 defibrillator could cause a failure to deliver life-saving shocks, resulting in an FDA Class I recall classification.…
Medical devices and hospitals are dangerously vulnerable to cybersecurity breaches, according to a presentation at a recent cybersecurity conference.…
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.…
Hundreds of thousands of St. Jude heart implants worldwide may have batteries that can fail prematurely, leading to serious injury or death to patients with hearth rhythm problems.…
Medtronic warns that it’s VIva CRT-Ds and Evera ICDs may rapidly drain batteries, which can result in device failure. …
A new study warns that patients receiving implantable cardioverter-defibrillators face high risks of complications associated with long-term use.…
The FDA has classified a Covidien electrode safety warning as a class 1 recall following the death of a patient.…
Danish researchers say St. Jude Riata lead problems are worsening and are recommending some patients risk heart surgery to get the defective leads replaced.…
