Boston Scientific Recalls 200 Defective Drug-Coated Stents Due to Manufacturing Defect

Boston Scientific Corp., a leading medical equipment manufacturer, has issued a recall for 200 of its recently approved drug-coated coronary stents due to a malfunction that has been linked to at least one death. The company attributed the defect to a manufacturing issue that has since been addressed. The recalled stents, part of the Taxus Express2 line, were approved for sale in the US in March and had been implanted in about 445,000 patients.

Key Takeaways:

• The recall affects 200 defective Taxus Express2 stents, which were manufactured in two recent lots.
• The malfunction can prevent the stent's balloon from deflating, leading to death or requiring bypass surgery.
• Boston Scientific reported one death and 16 serious injuries related to the deflation failure.
• The recall does not affect patients who have already received a Taxus stent, as the problem occurs only at the time of implantation.
• The company is notifying 99 US hospitals and 3 Canadian hospitals that have received the recalled stents.
• The Taxus stent was launched in Europe in February and approved for sale in the US in March.

Statistics:

• At least one death has been linked to the malfunction.
• 16 serious injuries have been reported due to the deflation failure.
• 200 defective stents are being recalled.
• About 445,000 of the Taxus stents have been implanted.
• The recall affects two recent manufacturing lots of the Taxus Express2 stents.

Sources:

• Boston Scientific Corp.
• US Food and Drug Administration.
• Cardiovascular Week via NewsRx.com & NewsRx.net.