FDA MedWatch

Foreign particle contamination of several products manufactured by Genzyme, which may lead to serious adverse events including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions.

Reports of loss of device height, which may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for surgery to modify the implanted device.

14 events reported in which a 200 J biphasic defibrillator was ineffective in providing fibrillation / cardioversion therapy to a patient.

Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery.

Product containers may contain particulate matter that could act as emboli and lead to impeded blood flow.

Consumers warned that product sold as a dietary supplement contains sulfoaildenafil.

Kits recalled because the pediatric tracheal tubes were manufactured with an internal diameter smaller than indicated on the label.

Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury.

Cases of altered kidney function, including acute renal failure and renal insufficiency, in patients using Byetta.

Nationwide recall of all size kits. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.