Last Build Date: Tue, 25 Oct 2016 12:29:00 -0400
Tue, 25 Oct 2016 12:29:00 -0400New Warning and updated Abuse and Dependence sections of labeling, including new safety information from published literature and case reports.
Mon, 24 Oct 2016 00:00:00 -0400Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.
Thu, 20 Oct 2016 14:00:00 -0400Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention.
Thu, 20 Oct 2016 09:30:00 -0400The FDA is concerned that health care providers may be unaware of the risks associated with these devices.
Tue, 18 Oct 2016 12:01:00 -0400PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.
Fri, 14 Oct 2016 14:30:00 -0400User may not be able to connect electrodes to Welch Allyn AED model 10 defibrillator, which may result in a delay in delivering the electrical therapy.
Thu, 13 Oct 2016 15:00:00 -0400New information about M. chimaera infections, and updated recommendations to help prevent the spread of infection.
Tue, 11 Oct 2016 10:20:00 -0400In some cases full battery drainage can occur within a day to a few weeks after patient receives ERI alert. If battery runs out, ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.
Wed, 05 Oct 2016 13:50:00 -0400Excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.
Wed, 05 Oct 2016 13:50:00 -0400The effects of Burkholderia cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.
Tue, 04 Oct 2016 13:40:00 -0400FDA requiring a Boxed Warning about the risk of HBV reactivation to be added to drug labels, directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment.
Mon, 03 Oct 2016 14:30:00 -0400Bacteria and/or particulate matter present in an unsterile solution could pass through to a compounded prepared solution, which could lead to adverse health consequences.
Fri, 30 Sep 2016 14:00:00 -0400Adverse events reported to the agency, including seizures in infants and children who were given these products.
Wed, 28 Sep 2016 14:40:00 -0400Potential for the adaptors to produce extreme internal pressure, which may cause the device to explode. The use of affected products may cause serious adverse health consequences, including death.
Thu, 22 Sep 2016 14:50:00 -0400Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening.
Thu, 15 Sep 2016 11:20:00 -0400Adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation.
Fri, 09 Sep 2016 14:07:00 -0400Affected product with detached needle cannot be used as prescribed. Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal.
Thu, 08 Sep 2016 08:20:00 -0400Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.
Wed, 07 Sep 2016 17:17:00 -0400Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.
Wed, 07 Sep 2016 14:40:00 -0400Using unproven ovarian cancer screening tests may be harmful for women with increased risk for developing ovarian cancer.