Boston Scientific Corp. has recalled its implantable heart defibrillators after it failed to alert regulators of manufacturing changes. The medical device company stated that it had no reason to believe the manufacturing changes presented a threat to patient safety and did not advise physicians to remove the implantable devices from patients. Boston Scientific has described the issue as a “documentation problem” and is currently developing a resolution with the FDA.
The FDA has previously warned Boston Scientific about failing to adhere to reporting requirements. In 2006, the FDA issued a warning to Boston Scientific for failure to report problems with its medical devices and prohibited the company from releasing new products into the U.S. market until the issues were resolved. A year later, Boston Scientific was warned after allegedly failing to report two deaths in a clinical trial.
Medical device manufacturers are required to obtain permission from the FDA before making changes to their products. This review typically takes 30 days and ensures the safety and effectiveness of the products are not compromised. Boston Scientific told the FDA that it failed to file for approval and would withdraw the implantable defibrillators. The current recall is expected to take a heavy toll on the company, which attributed 15% of its 2009 revenue to the life-saving devices.
Boston Scientific did not describe the withdrawal of the defibrillators as a “recall”. Rather, the company stated that it was stopping shipments and retrieving products that had already been delivered. The FDA, however, cited the action as a “recall.” Boston Scientific stated that it ensured the changes complied with FDA regulations, but did not ask the agency to approve these changes. The manufacturing changes that sparked the recall were not identified.
Defibrillators are implanted into the chests of patients. These life-saving devices return an abnormal heartbeat to a regular rhythm by supplying an electronic shock to the heart. Implantable defibrillators are a major portion of the medical device industry, making more than $4 billion dollars in revenue last year.