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Medical equipment industry

Boston Scientific Expands Recall of TAXUS Express2 Paclitaxel-Eluting Coronary Stent Systems

Strategic Insights

— 2 min read

Boston Scientific has announced that it is expanding its voluntarily worldwide recall to include certain additional units of its TAXUS Express2 Paclitaxel-Eluting Coronary Stent Systems, due to potential characteristics in the delivery catheters that can impede balloon deflation during a coronary angioplasty procedure. This recall affects approximately 85,000 TAXUS stent systems and 11,000 Express2 stent systems, in addition to the initial recall of 200 TAXUS Express2 Paclitaxel-Eluting Coronary Stent Systems announced on July 2. The company has identified additional production lots that may exhibit these characteristics, and while the number of reported balloon deflation difficulties is extremely small, patient safety is the company's top priority. The recall is expected to impact the financial results for the second quarter, with an estimated revenue reversal of approximately $45 million (pre-tax) and a write-down of inventory of approximately $50 million (pre-tax).

Key Takeaways:

  • Boston Scientific has expanded its voluntary recall of TAXUS Express2 Paclitaxel-Eluting Coronary Stent Systems to include additional units due to potential issues with the delivery catheter.
  • The recall affects approximately 85,000 TAXUS stent systems and 11,000 Express2 stent systems, in addition to the initial recall of 200 TAXUS Express2 Paclitaxel-Eluting Coronary Stent Systems announced on July 2.
  • Patient safety is Boston Scientific's top priority, and the company has implemented a review of its manufacturing process, additional inspections, and an FDA-approved modification to the manufacturing process for these products.
  • The recall does not affect patients who have already received the stents, as the difficulty lies with the delivery system and occurs at the time of insertion, not afterward.
  • Boston Scientific expects some disruption in service as a result of the recall, particularly internationally, and has notified the U.S. Food and Drug Administration (FDA) and plans to notify officials in other affected countries.
  • The company will reschedule the announcement of its financial results for the second quarter and will discuss the recall on a conference call at 3:45 p.m. (ET) today.

Statistics:

  • 85,000 TAXUS stent systems recalled
  • 11,000 Express2 stent systems recalled
  • 200 initial recall of TAXUS Express2 Paclitaxel-Eluting Coronary Stent Systems announced on July 2
  • 18 serious injuries and one death associated with balloon deflation for the TAXUS stent system
  • 25 serious injuries and two deaths associated with balloon deflation in the Express2 (bare metal) stent system
  • More than 500,000 TAXUS stent systems shipped
  • More than 600,000 Express2 stent systems shipped
  • $45 million (pre-tax) revenue reversal expected as a result of the recall
  • $50 million (pre-tax) write-down of inventory expected as a result of the recall

Sources:

  • Boston Scientific Corp.
  • Angiotech Pharmaceuticals, Inc.
  • U.S. Food and Drug Administration (FDA)

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