Federal regulators found problems with an implanted drug-infusion port, and its maker, Boston Scientific Corp., is advising doctors to consider surgery on patients who received any of the 1,000 ports recalled in March.
The company also said it would recall another 1,000 ports this week, after it received a warning letter from the Food and Drug Administration about quality-control standards.
The problems could cause the ports to leak drugs into unintended parts of the body. Boston Scientific said it knew of just one possible report of a patient injury.
The FDA letter, posted on the Boston Scientific Web site, said the company failed to establish manufacturing controls for the quality of the devices and did not properly track quality concerns. The FDA instructed the company to fix problems it called "serious violations of the law."
Boston Scientific said it would take charges totaling $2 million to resolve the issues.
Infusion ports make it easier to treat patients who need frequent drug injections by avoiding repeated needle-sticks directly into a blood vessel.
Boston Scientific started reviewing its manufacturing procedures last August after receiving a complaint that two plastic pieces that form the infusion port's cover and base had separated. The company received at least four more complaints over the next six months and on March 9 launched a voluntary recall of all 1,000 ports it had shipped to date.
At the time, Boston Scientific said it didn't need to recall ports made without valves because the company hadn't received complaints about those models.
But the FDA's letter said it did receive a complaint Jan. 5 about a "leak in the membrane" of a nonvalved port. The company decided to recall those ports this week to address the FDA's concerns, Boston Scientific spokesman Charles Rudnick said.
Of the ports that have already been recalled, the company is trying to determine how many have been implanted in patients, Rudnick said. The company is only advising doctors to consider removing the devices, he said.
The ports are typically removed after about six months.
Boston Scientific isn't advising doctors whose patients have the nonvalved port to consider removing them because the company hasn't received any reports of the cover and base separating, Rudnick said.