Warning Issued to Stent Maker

Federal regulators sent Boston Scientific Corp. a warning letter identifying “serious regulatory problems” in medical devices shipped from a Quincy, Mass., distribution center, including heart stents sent to hospitals despite a quality control problem.

A letter to the company dated Aug. 10 said Food and Drug Administration inspectors found “serious regulatory problems” during a nearly two-month inspection in Quincy that ended May 20. The letter cited problems in shipments of the company’s Taxus drug-coated stents -- Boston Scientific’s top-selling product -- as well as Vaxcel implantable infusion ports used to administer drugs and Symmetry catheters that insert medical devices.

Charles Rudnick, a spokesman for Natick, Mass.-based Boston Scientific, said the company “is actively working on every point raised in the FDA letter. We’ve completed corrective action in many areas.”

Rudnick said none of the problems with shipments cited in the FDA letter harmed patients. Eight Taxus stents that were shipped to five hospitals in January, even though they were in a batch that had previously failed to meet quality standards, were returned to the company before they were used, Rudnick said. The drug-coated stents failed to pass a test involving their release of drugs to prevent scar tissue from forming new blockages after artery-clearing surgery.

However, the FDA’s letter, posted on the agency’s website Tuesday, said the problems it cited “may be symptomatic of serious underlying problems in your establishment’s quality system.”

The letter said “these serious violations of the law may result in the FDA taking regulatory action without further notice to you,” including such possible steps as seizing product inventory, obtaining a court order to halt marketing of devices, or fining the company.

Rudnick said the Quincy center distributed most of the company’s medical devices, which are produced at various manufacturing sites. He said the FDA highlighted problems only at the distribution center, not systemic problems in the company’s manufacturing.

Boston Scientific last summer recalled nearly 100,000 units of the Taxus stent and another model not coated with drugs because of a manufacturing defect that the company has since fixed.

Stents are metal-mesh devices that prop open coronary arteries after surgeries to clear blockages.

Shares of Boston Scientific declined $1.23 to $25.92.