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MedWatch Safety Alert

HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues

A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.


Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.


Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events

Increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with metallic XIENCE drug-eluting stent.


Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder

Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.


SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus

Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.


Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery

Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017


Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices

Nationwide recall of Regeneca's entire line of herbal and dietary supplement products.


SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination

Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria.


Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures

Procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials