Report: Boston Sci hit with subpoena after ICD, CRT-D recall
After Boston Scientific voluntarily ceased shipment of all its implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) for failing to notify the FDA of manufacturing changes, the Wall Street Journal (WSJ) has reported that the company is now being probed by the Department of Justice (DoJ) and the Securities and Exchange Commission (SEC).
The WSJ reported that the subpoena slapped to Boston Scientific cites an internal company memo and is asking for more detailed information regarding the March 15th recall of its ICD and CRT-D devices.
On Monday, Natick, Mass.-based Boston Scientific held a conference call with physicians to provide more detailed information and background regarding the recall.
According to a transcript furnished by the SEC, “During an internal documentation review, our teams discovered that two validated manufacturing changes had not been submitted to the FDA for approval,” said Ray Elliott, president and CEO of the company.
Elliott said during the call that the company had been using the same cleaning process for its line of defibrillators and pacemakers; however, the devices had different cycle times. In a decision to standardize these cycle times, he said the company “failed to file the defibrillator process change for approval with the FDA.”
While he said that “in both cases, the manufacturing changes were fully validated and met the stringent requirements of our own internal quality system,” the company “simply failed to file the required documentation with the FDA.”
The company has since filed the necessary documents with the FDA for "30-day notice" for approval, according to Elliott. However, the FDA “indicated last week that it is not taking steps to expedite review of our applications, and said that “It appears we will have to wait our turn in the queue.”
Days after the recall, the FDA issued a statement on March 19 stating it was not aware of any new safety risks concerning the recalled devices, but advised physicians to discontinue use until the agency had approved the changes submitted by Boston Scientific.
“The actions we took on March 15 were the result of an error in our submission process. They were not related to product quality of patient safety,” Elliot concluded.
During the call, the company made no mention of the alleged subpoena filed by the SEC or DoJ.
The WSJ reported that the subpoena slapped to Boston Scientific cites an internal company memo and is asking for more detailed information regarding the March 15th recall of its ICD and CRT-D devices.
On Monday, Natick, Mass.-based Boston Scientific held a conference call with physicians to provide more detailed information and background regarding the recall.
According to a transcript furnished by the SEC, “During an internal documentation review, our teams discovered that two validated manufacturing changes had not been submitted to the FDA for approval,” said Ray Elliott, president and CEO of the company.
Elliott said during the call that the company had been using the same cleaning process for its line of defibrillators and pacemakers; however, the devices had different cycle times. In a decision to standardize these cycle times, he said the company “failed to file the defibrillator process change for approval with the FDA.”
While he said that “in both cases, the manufacturing changes were fully validated and met the stringent requirements of our own internal quality system,” the company “simply failed to file the required documentation with the FDA.”
The company has since filed the necessary documents with the FDA for "30-day notice" for approval, according to Elliott. However, the FDA “indicated last week that it is not taking steps to expedite review of our applications, and said that “It appears we will have to wait our turn in the queue.”
Days after the recall, the FDA issued a statement on March 19 stating it was not aware of any new safety risks concerning the recalled devices, but advised physicians to discontinue use until the agency had approved the changes submitted by Boston Scientific.
“The actions we took on March 15 were the result of an error in our submission process. They were not related to product quality of patient safety,” Elliot concluded.
During the call, the company made no mention of the alleged subpoena filed by the SEC or DoJ.