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FDA MedWatch Safety Alerts
Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected
UPDATED 10/19/2017. St. Jude Medical notified physicians of the Battery Performance Alert (BPA), a new tool that detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion.
Posted: October 19, 2017, 7:30 pm
Product tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.
Posted: October 7, 2017, 4:00 am
Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall - One Shipment of Product Exposed to Subfreezing Temperatures
When subjected to freezing, emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation/lead to serious adverse health consequences that can be life-threatening.
Posted: October 6, 2017, 3:00 pm
Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin (TMV) Formulation: FDA Statement - Case of Hemorrhagic Occlusive Retinal Vasculitis
Prophylactic use of intraocular vancomycin, alone or in a compounded drug, during cataract surgery is generally not recommended because of the risk of HORV.
Posted: October 3, 2017, 7:00 pm
FDA reminding parents and caregivers not to put babies in sleep positioners. These products, sometimes also called “nests” or “anti-roll” products, can cause suffocation that can lead to death.
Posted: October 3, 2017, 2:00 pm
Endovascular Graft Systems: Letter to Health Care Providers - Type III Endoleaks Associated with Use
Type III endoleak may require treatment with additional interventions such as re-lining, insertion of additional endograft components, or open surgical repair. Interventions to address endoleaks carry added risks for impacted patients.
Posted: September 28, 2017, 3:00 pm
Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Class I Recall - Risk of Blocked Guidewire Lumen Preventing Balloon Utilization
If device with blocked guidewire lumen were used, device would not be positioned correctly and hemorrhage would not be controlled, delaying life-saving treatment, which may result in serious adverse health consequences, including death.
Posted: September 26, 2017, 11:00 am
TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results
UPDATED 09/25/2017. Most recent interim results from the ongoing SynCardia TAH-t post-approval study looking at mortality and neurological adverse events.
Posted: September 25, 2017, 5:30 pm
Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that, taken with this product, could lower blood pressure to dangerous levels that could be life-threatening.
Posted: September 21, 2017, 5:00 pm
Reports of Ocaliva being incorrectly dosed in some patients with moderate to severe decreases in liver function. Some patients received a higher frequency of dosing than is recommended in the drug label.
Posted: September 21, 2017, 2:00 pm
Rhino 7, Papa Zen, Fifty Shades, and Grande X Dietary Supplements by Gadget Island: Recall - Undeclared Drug Ingredients
Use of products with undeclared active ingredients sildenafil, tadalafil and desmethyl carbodenafil may interact with nitrates and may cause a significant drop in blood pressure that may be life threatening.
Posted: September 20, 2017, 9:41 pm
Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants: Drug Safety Communication - Careful Medication Management Can Reduce Risks
Health care professionals should develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants.
Posted: September 20, 2017, 4:00 pm
Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification – Potential for Counterfeit Raw Material
UPDATED 09/19/2017 Updating after extensive review of data and information.
Posted: September 19, 2017, 4:00 am
OriGen VV28F Reinforced Dual Lumen ECMO Catheters: Recall - Potential for Separation of Extension Tube From Hub
Separation could result in required intervention to prevent permanent impairment/damage.
Posted: September 13, 2017, 6:00 pm
Diabetes Infusion Sets by Medtronic: Recall - Vent Membrane May be Susceptible to Being Blocked by Fluid
May lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Posted 09/12/2017
Posted: September 12, 2017, 4:00 am
If not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.
Posted: September 8, 2017, 6:00 pm
The use of impacted Sterile Water for Injection could result in adverse events such as fever, chills, phlebitis, and granuloma or more severe adverse events such as sepsis or invasive systemic infections.
Posted: September 7, 2017, 4:00 am
Intra-Aortic Balloon Pumps by Datascope/MAQUET: Class I Recall - False Blood Detection Alarm, Ingress of Fluid Into Pump
If therapy is stopped during use without a replacement IABP available, device failure may result in immediate and serious adverse health consequences, including death.
Posted: September 6, 2017, 5:00 pm
Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing
Too much potassium in the blood can cause problems with heart rhythm, which in rare cases can be fatal.
Posted: September 6, 2017, 1:00 pm
Hydromorphone HCl Injection, USP 2 mg/mL, and Levophed (Norepinephrine Bitartrate Injection, USP) 4 mg/4 mL (1 mg/mL) Vial by Hospira: Recall - Lack of Sterility Assurance
If impacted product is administered to a patient, adverse events ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection could occur.
Posted: September 5, 2017, 7:00 pm