Boston Scientific Corporation is expanding its voluntarily worldwide recall to include certain additional units of its Taxus Express2 Paclitaxel-Eluting Coronary Stent Systems. The Company is also beginning a voluntary recall of certain units of its Express2 Coronary Stent Systems (bare metal stents). The Company has notified the US FDA and plans to notify officials in other affected countries, according to a press release.
On July 2, the Company announced the recall of approximately 200 Taxus Express2 Paclitaxel-Eluting Coronary Stent Systems, due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure. Since then, the Company has conducted further analysis and investigation of the Taxus Express2 (paclitaxel-eluting) and Express2 (bare metal) stent systems, both of which share the same delivery catheter, and has identified additional production lots which may exhibit these characteristics.
While the number of customer reports of balloon deflation difficulty is extremely small, patient safety is the Company's paramount concern, and therefore it has chosen to initiate this broader recall. Impeded balloon deflation can result in significant patient complications, including coronary artery bypass graft surgery and death. The Company has received reports of one death and 18 serious injuries associated with balloon deflation for the Taxus stent system, and two deaths and 25 serious injuries associated with balloon deflation in the Express2 (bare metal) stent system. The units being recalled were manufactured at the Company's Galway, Ireland and Maple Grove, Minnesota facilities, the release added.
The recall will involve approximately 85,000 Taxus stent systems and approximately 11,000 Express2 stent systems. Overall, the Company has shipped more than 500,000 Taxus stent systems and more than 600,000 Express2 stent systems. The recall does not affect the Express SD and LD biliary stent systems.
The Company implemented review of its manufacturing process, additional inspections, and an FDA-approved modification to the manufacturing process for these products.
"Patient safety continues to be our highest priority," said Jim Tobin, president and CEO of Boston Scientific. "We have every confidence these products are safe and effective, and we expect that these measures will go a long way toward reducing the occurrence of these events. We regret any disruption this recall may cause to physicians and their patients," he added.