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Abiomed's so-called recall of some models of its Impella Left Sided Blood Pumps, used in some high-risk heart procedures to provide short-term support, was because of the possibility they could ...
Use of the device may cause serious injury, including blood loss, artery tears, unstable blood pressure, prevention of blood flow to the heart, or death, according to the FDA.
The FDA staff's assessment comes ahead of meetings of two independent expert panels next week, where they will make recommendations on whether or not to approve the devices for treatment. The ...
The same panel on Tuesday voted in favor of rival ReCor's device for use in a surgery called renal denervation in patients whose high blood pressure cannot be controlled by drugs. Separately ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
The FDA panel backed the use of the device made by the Japanese company's unit ReCor for renal denervation, which is indicated for use in patients whose hypertension, or high blood pressure ...
Before taking the test, the patient may be instructed to fast for a period before the test will take place and to stop taking any medications. On the day of the tilt table test, an intravenous line may be placed in case the patient needs to be given medications quickly; however, this may influence the results of the test and may only be indicated in particular circumstances.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]