FDA calls Medtronic drug pump warning Class I.Medtronic said March 19 that U.S. regulators classified its move to inform physicians about an increase in the rate of inflammatory mass cases in patients receiving drugs through the company's implantable infusion pumps infusion pump A device designed to deliver drugs and/or 'biologicals', at low doses and at a constant or controllable rate; ↑ rates of delivery in such devices may be associated with local hemolysis, compromising the potential benefits of a calibrated delivery as a Class I recall, Reuters reported. The medical device maker said no deaths have been associated with the problem and the recall classification does not change recommendations made to physicians in January. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. defines a Class I recall as a situation in which there is a reasonable probability that use of the product will cause injury or death. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the FDA website, a medical device recall does not always mean that patients or doctors must stop using the product or return it to the company. A recall sometimes means the medical device needs to be checked, adjusted or fixed. Medtronic said in a statement that it sent an update on January 16 to inform clinicians of an increase in the rate of inflammatory mass cases reported in patients using its SynchroMed and IsoMed infusion systems. The masses developed near the tip of the catheter catheter /cath·e·ter/ (kath´e-ter) 1. a tubular, flexible surgical instrument that is inserted into a cavity of the body to withdraw or introduce fluid. 2. urethral c. attached to the pumps, which are typically used to dispense opioids Opioids One of the major classes of semi or fully synthetic psycho-active drugs that includes methadone. Mentioned in: Cancer Therapy, Palliative, Methadone opioid for pain. Medtronic said the risk of an inflammatory mass has been part of the product labeling since 2001. |
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