Boston Scientific to Recall Infusion PortsJun 1, 2005 | UPI Boston Scientific Corp. said it will recall another 1,000 drug infusion ports in response to a stern warning from the U.S. Food and Drug Administration.
The FDA warning, issued May 18 and posted this week on its Web site, said Boston Scientific failed to establish quality controls for making the infusion ports and failed to properly track quality concerns, including leaking, that the FDA called "serious violations of the law."
Hundreds of patients may need surgery to remove the device, the company told the Boston Globe.
The ports, about the size of a 50-cent piece and implanted under the skin, deliver drugs through a catheter attached to a vein.
They are used often for cancer patients or others who need frequent drug injections.
The second recall would bring to 2,000 the number of Boston Scientific drug infusion ports recalled this year.