8-KOther Events

BOSTON SCIENTIFIC CORP 8-K Report, Corporate Update (Mar 15, 2010)

Filed March 15, 2010For Securities:BSX

Summary

Boston Scientific Corporation (BSX) has filed an 8-K report on March 15, 2010, announcing a significant event: the company is halting shipments and initiating a recall of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). This action stems from the discovery that certain manufacturing process changes were not submitted for approval to the U.S. Food and Drug Administration (FDA), despite being validated and, to the company's current knowledge, not posing a risk to patient safety. No explantation of devices is being recommended. The immediate consequence of this recall is a potential material impact on Boston Scientific's financial outlook. The company explicitly states that this situation could materially affect previously issued guidance concerning revenue, operating profit, and cash flows for both the first quarter and the full fiscal year 2010. Investors should closely monitor any further updates from the company and the FDA regarding the resolution of this issue and its financial repercussions.

Key Highlights

  • 1Boston Scientific is stopping shipment and recalling all ICD and CRT-D devices.
  • 2The reason for the recall is that certain manufacturing process changes were not submitted to the FDA for approval.
  • 3The company has identified two such changes that, while validated, lacked FDA submission.
  • 4Boston Scientific has informed the FDA and plans to collaborate on a resolution.
  • 5The company currently has no indication that the manufacturing changes pose a risk to patient safety.
  • 6No explantation of affected devices is being recommended to patients.
  • 7The recall is expected to have a material impact on the company's 2010 financial guidance for revenue, operating profit, and cash flows.

Frequently Asked Questions

Boston Scientific is halting shipments and recalling its ICD and CRT-D devices because it discovered that certain manufacturing process changes were made without prior submission and approval from the U.S. Food and Drug Administration (FDA), despite being validated internally.

According to Boston Scientific, they currently have no indication that the manufacturing process changes pose any risk to patient safety, and they are not recommending that patients have their devices explanted.

The company acknowledges that this situation could materially impact its previously issued financial guidance for the first quarter and full year of 2010, specifically affecting revenue, operating profit, and cash flows.

Boston Scientific has informed the FDA of the situation and plans to work closely with the agency to resolve it as soon as possible. The company is also recalling field inventory and stopping shipments of the affected devices.