FDA MedWatch

Device computer may shut down without an alarm, which can lead to serious injuries or death.

Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.

UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010

Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.

Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.

Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.

Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).

FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.

Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.

FDA requires risk management plan and class-labeling changes for all LABAs.

Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.

Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin.

FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.

Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.

Device may not be able to deliver therapy during a cardiac resuscitation attempt.

Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.

Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.

Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.

Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.