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FDA MedWatch Safety Alerts
HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: Class I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange
A slow or improper driveline changeover places certain patients at risk of serious injury or death.
Posted: May 23, 2017, 9:06 pm
Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients
Use or consumption of products containing SARMs and anabolic steroid-like substances may cause acute liver injury, which is known to be a possible harmful effect of using steroid containing products.
Posted: May 22, 2017, 6:50 pm
Unexpected stop in ventilation therapy may cause serious adverse health consequences, including death.
Posted: May 22, 2017, 5:30 pm
Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention
Health care professionals should continue to limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs.
Posted: May 22, 2017, 1:00 pm
LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results
Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.
Posted: May 17, 2017, 1:20 pm
Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction.
Posted: May 16, 2017, 3:00 pm
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations
New warnings, including a Boxed Warning, to be added to the canagliflozin drug labels.
Posted: May 16, 2017, 1:00 pm
UPDATED 5/8/2017. C.O. Truxton expands their 04/21/2017 recall to include additional products.
Posted: May 8, 2017, 7:30 pm
GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds: Recall - Presence of Anabolic Steroids
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.
Posted: May 8, 2017, 12:15 pm
HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device by Medtronic: Recall - May Cause Electrical Issues or Pump Stops
An interruption in electrical connection may cause the pump to stop, which may lead to serious adverse health consequences, including death.
Posted: May 5, 2017, 6:10 pm
Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall - Updated Controller, Power Management Software
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.
Posted: May 4, 2017, 5:30 pm
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.
Posted: May 3, 2017, 7:00 pm
Minor and serious injuries, including two patient deaths, following procedures that involved the use of non-Medtronic instruments with Medtronic's NavLock Tracker.
Posted: May 3, 2017, 1:55 pm
Newport HT70 and HT70 Plus Ventilators by Medtronic: Field Corrective Action - Ventilator May Reset Spontaneously
UPDATED 05/02/2017. Class I Recall. Potential for ventilator reset during normal operation, without an accompanying alarm.
Posted: May 2, 2017, 7:01 pm
General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children
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.
Posted: April 27, 2017, 5:15 pm
Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure
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.
Posted: April 25, 2017, 1:25 pm
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.
Posted: April 24, 2017, 2:05 pm
Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women
New and strengthened WARNINGS and CONTRAINDICATIONS on drug labels describing serious risks, including slowed or difficult breathing and death.
Posted: April 20, 2017, 3:30 pm
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.
Posted: April 19, 2017, 12:55 pm
Updated 04/13/2017. Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children.
Posted: April 13, 2017, 11:00 pm