Boston Scientific Defibrillator Recall: Unapproved Manufacturing Changes

Boston Scientific has been forced to recall several models of implantable heart defibrillators after failing to notify the FDA that it made changes to the devices’ designs. 

The company announced that it was stopping shipment and retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) in a press release on March 15. The company said that it decided to pull the devices from the market after realizing that some changes in how the devices were manufactured were not submitted to FDA for approval, as required by federal law. The FDA has classified the action as a medical device recall.

The implants are used to monitor patients’ hearts for abnormal heart rhythms and then deliver electric shocks to keep the heart beating at the proper rhythm.

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Boston Scientific says that it does not believe there is any safety concern for people who have had the devices implanted, and have classified the defibrillator recall as a filing error. However, analysts say that the recall of the defibrillators, which account for 15% of the company’s revenue, could cost $5 million per day until the manufacturing processes are approved.

The recall comes less than a month after the Department of Justice filed criminal charges against Guidant LLC, a Boston Scientific subsidiary, for allegedly hiding information regarding catastrophic failures of its Ventak Prizm 2 DR and Contak Renewal ICDs that, in some cases, resulted in death. Boston Scientific announced last November that it intends to pay $296 million in connection with the charges against Guidant. The DOJ says it expects that Boston Scientific is likely to enter a guilty plea in connection with the charges.

The criminal charges are related to earlier defibrillator manufacturing changes that prosecutors say were done to cover up deaths from defective defibrillator designs. The DOJ charges say that Guidant failed to inform the FDA of the changes in order to avoid scrutiny. The company continued to find problems with its defibrillators, and prosecutors say the company sent product updates to physicians that it did not send to FDA, as required by law, and even after other problems with other ICDs developed, the company did not issue a warning about the failures until June 2005.

The FDA determined that the warnings constituted Class 1 medical device recalls, the most serious category of recalls, which indicate that a product has the probability of causing serious injury or death.

The Prizm series, which was included in the criminal investigation, is also one of the units affected by the latest recall for unapproved manufacturing changes. Other defibrillator lines affected by the recall include the Cognis, Confient, Livian, Renewal, Teligen and Vitality ICDs and CRT-Ds.

Boston Scientific says it plans to work closely with FDA to get the manufacturing changes approved and quickly make the defibrillators available on the market again.

5 Comments

  • JoeleneMarch 24, 2014 at 5:29 am

    Anyone having persistent shocks or any symptoms should see the cardiologist and have their devices checked out. You could be getting inappropriate shocks or not. Best to be safe. Ask your doctors to inform you if there are any recalls or concerns being investigated regarding your make and model. You can also call the company and get information. You also can research the internet or have some[Show More]Anyone having persistent shocks or any symptoms should see the cardiologist and have their devices checked out. You could be getting inappropriate shocks or not. Best to be safe. Ask your doctors to inform you if there are any recalls or concerns being investigated regarding your make and model. You can also call the company and get information. You also can research the internet or have someone do it for you. Knowledge is power!

  • EiraApril 10, 2012 at 1:36 am

    I have a defibrilator implanted on 2010, Boston Scientific ALTRUA 40 SN 576297 I am experiencing continuous chocking sensation that literally takes my breath away, causing me to be in bed some times for days due to the lack of energy and dizziness, should I therefore be concern regarding this device? I did have an incident were I had a white out at a store were I became onconcious, I was told a[Show More]I have a defibrilator implanted on 2010, Boston Scientific ALTRUA 40 SN 576297 I am experiencing continuous chocking sensation that literally takes my breath away, causing me to be in bed some times for days due to the lack of energy and dizziness, should I therefore be concern regarding this device? I did have an incident were I had a white out at a store were I became onconcious, I was told at the ER that I had a zeasure could this be a cause of a malfunction of my device?

  • d-bJuly 2, 2011 at 10:08 pm

    my uncle just went to the er , his defib was shocking him over and over again. any thoughts?

  • LarryApril 6, 2010 at 9:43 pm

    I have a Guidant defibrilator implanted in my chest and I have trouble sometimes and it shocks me. I had to go to ememrgency on a couple of occasions. I am not sure that this deviceis safe for me.

  • TonyMarch 17, 2010 at 4:08 pm

    Will they publish the model numbers of the defribrillators involved in the controversy?

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