U.S. FDA warns Boston Scientific
π₯ The U.S. FDA issued a warning letter to Boston Scientific regarding serious regulatory problems at its Massachusetts distribution plant.
π Heart stents were shipped to hospitals despite known quality issues, according to the FDA disclosure.
π Boston Scientific shares dropped nearly 5% in Tuesday morning trading, reaching a new 52-week low.
π¨π¦ Angiotech Pharmaceuticals Inc., Boston Scientific's Canadian partner, saw its shares fall about 2% on the Toronto Stock Exchange.
π¬ The FDA letter specifically cited quality problems with Taxus drug-coated stents, Vaxcel implantable infusion ports, and Symmetry catheters.
π Taxus drug-coated stents are Boston Scientific's top-selling product and were included in the regulatory warning.
π©Ί Stents are metal-mesh devices used to prop open coronary arteries after surgeries to clear blockages.
β Boston Scientific stated it is actively working on every point raised in the FDA letter.
π οΈ The company reported completing corrective actions in many areas addressed by the FDA.
π Boston Scientific confirmed that none of the shipment problems cited in the letter harmed patients.
π Last summer, Boston Scientific recalled nearly 100,000 units of Taxus stents due to a manufacturing defect.
π§ The company has since fixed the manufacturing defect that led to the previous recall.
π° Angiotech Pharmaceuticals derives most of its revenue and profit from royalties on Boston Scientific Corp.
- Boston Scientific stated it is actively working on every point raised in the FDA letter.
- The company reported completing corrective action in many areas identified by regulators.
- Management confirmed that none of the problems with shipments cited in the FDA letter harmed patients.
- The company previously recalled nearly 100,000 units of Taxus stents due to a manufacturing defect that has since been fixed.
- The U.S. FDA issued a warning letter citing 'serious regulatory problems' at Boston Scientific's medical device distribution plant in Massachusetts.
- Heart stents were shipped to hospitals despite identified quality issues, raising concerns about product safety and compliance.
- Boston Scientific shares dropped nearly five percent in morning trading to reach a new 52-week low following the disclosure.
- The FDA specifically cited problems with shipments of Taxus drug-coated stents, which is Boston Scientific's top-selling product.
- A previous recall last summer involved nearly 100,000 units of the Taxus stent and another non-drug-coated model due to a manufacturing defect.
- Angiotech Pharmaceuticals Inc., a Canadian partner that derives most of its revenue and profit from royalties on Boston Scientific Corp., saw shares fall about two percent.