Leerink Swann analysts confirmed that Boston Scientific Corp. (NYSE:BSX) pulled all field inventory of its implantable cardiac defibrillators and cardiac resynchronization therapy devices due to two manufacturing changes that were not properly documented with the Food & Drug Administration.
In a note sent to investors, the investment bank analysts wrote that physicians were sent an official communication from the Natick, Mass.-based medical devices giant, confirming speculation about the cause of the recall.
First, the company wrote that it had changed the cleaning process for its ICDs to bring it in line with an already approved process for cleaning its pacemakers. But the company did not notify the FDA of the change. According to the note, the change was made in March 2009.
Second, the company added a new component supplier in April 2009 for whom sub-component testing was performed, “but not appropriately reported to the FDA.”
The letter from BSX did not commit to any time frames, according to the analysts. The company has remained silent on the issue since the initial announcement.
Leerink, quoting an un-named doctor, said that assuming Boston Scientific gets back on its feet within its 30-day deadline, it will still take a good three to six months to return to pre-shipment hold levels. BSX arch-rivals Medtronic Inc. (NYSE:MDT) and St. Jude Medical (NYSE:STJ) are already seeing a lot of additional business while Boston Scientific sits on the bench, with Minneapolis-based Medtronic pulling in about two-thirds of that business.
The revelations came from the investment bank’s Analyst Pulse conference call, featuring remarks from “a high-volume U.S. electrophysiologist.”
Last week, the FDA issued a statement on the recall, saying that Boston Scientific informed the watchdog agency that it will submit a pre-market approval supplement for the changes. The agency said it hadn’t received any reports of injuries caused by the action.