Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.
Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction.
New warnings, including a Boxed Warning, to be added to the canagliflozin drug labels.
Use or consumption of products containing anabolic steroids may cause acute liver injury. Abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children.
An interruption in electrical connection may cause the pump to stop, which may lead to serious adverse health consequences, including death.
Loose connector may allow moisture to enter controller causing corrosion, electrical issues, reduced speaker volume and connection failures which could cause serious adverse health consequences, including death.
Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.
Minor and serious injuries, including two patient deaths, following procedures that involved the use of non-Medtronic instruments with Medtronic's NavLock Tracker.
Exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years.
Use of unproven or unapproved products may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment.
Particulate administered to a patient could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or systemic allergic response to the particulate.
Mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma or death.
New and strengthened WARNINGS and CONTRAINDICATIONS on drug labels describing serious risks, including slowed or difficult breathing and death.
Use of these products may pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels.
Updated 04/13/2017. Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children.
If left untreated, under-drainage can potentially lead to coma and death.
Voluntary recall of all lots of sterile products, to the hospital/user level.
Potential for ventilator reset during normal operation, without an accompanying alarm.
Failure to activate or increased force needed to activate may have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).
Tip could enter the patient's bloodstream, resulting in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death.