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FDA MedWatch Safety Alerts

Last Build Date: Tue, 25 Oct 2016 12:29:00 -0400


Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence

Tue, 25 Oct 2016 12:29:00 -0400

New Warning and updated Abuse and Dependence sections of labeling, including new safety information from published literature and case reports.

HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Contamination Causing Electrical Issues

Mon, 24 Oct 2016 00:00:00 -0400

Contamination 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.

Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use

Thu, 20 Oct 2016 14:00:00 -0400

Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention.

Radiation Therapy Devices by Multidata Systems International: Discontinue Use – Concerns about Risks to Patients

Thu, 20 Oct 2016 09:30:00 -0400

The FDA is concerned that health care providers may be unaware of the risks associated with these devices.

Medtronic Neurovascular Products: Recall - Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

Tue, 18 Oct 2016 12:01:00 -0400

PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.

Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue

Fri, 14 Oct 2016 14:30:00 -0400

User 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.

Stӧckert 3T Heater-Cooler System by LivaNova PLC (formerly Sorin Group Deutschland GmbH): UPDATED Safety Communication - Reports of Mycobacterium Chimaera Infections

Thu, 13 Oct 2016 15:00:00 -0400

New information about M. chimaera infections, and updated recommendations to help prevent the spread of infection.

Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected

Tue, 11 Oct 2016 10:20:00 -0400

In 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.

Twin-Pass Dual Access Catheters by Vascular Solutions: Recall - Potential for Excess Manufacturing Material At The Tip

Wed, 05 Oct 2016 13:50:00 -0400

Excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.

I.V. Flush Syringes by Nurse Assist: Recall - Potential Link to Burkholderia Cepacia Bloodstream Infections

Wed, 05 Oct 2016 13:50:00 -0400

The effects of Burkholderia cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.

Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating

Tue, 04 Oct 2016 13:40:00 -0400

FDA 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.

50mm 0.2 Micron Filters by Baxter: Recall - Potential for Missing Filter Support Membrane, Particulate Matter

Mon, 03 Oct 2016 14:30:00 -0400

Bacteria and/or particulate matter present in an unsterile solution could pass through to a compounded prepared solution, which could lead to adverse health consequences.

Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children

Fri, 30 Sep 2016 14:00:00 -0400

Adverse events reported to the agency, including seizures in infants and children who were given these products.

Small Battery Drive and Small Battery Drive II Adaptor and Light Adaptor by DePuy Synthes: Class I Recall - Possible Explosion Risk

Wed, 28 Sep 2016 14:40:00 -0400

Potential 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.

Sterile Products by Wells Pharmacy Network: Recall - Concern for Lack of Sterility Assurance

Thu, 22 Sep 2016 14:50:00 -0400

Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening.

Hyoscyamine Sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results

Thu, 15 Sep 2016 11:20:00 -0400

Adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation.

GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe

Fri, 09 Sep 2016 14:07:00 -0400

Affected product with detached needle cannot be used as prescribed. Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal.

Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination

Thu, 08 Sep 2016 08:20:00 -0400

Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.

Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination

Wed, 07 Sep 2016 17:17:00 -0400

Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.

Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use

Wed, 07 Sep 2016 14:40:00 -0400

Using unproven ovarian cancer screening tests may be harmful for women with increased risk for developing ovarian cancer.