Guidant is recalling approximately 73,000 Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) that are distributed worldwide. The affected devices distributed in the US include the Contak Renewal 3 HE CRT-Ds (Models H177 and H179); Contak Renewal 3 CRT-Ds (Models H170 and H175); Vitality 2 DR ICDs (T165); Vitality 2 VR ICDs (T175); Vitality AVT ICDs (A155); Vitality DS DR ICDs (T125); and Vitality EL DR ICDs (T135). Guidant merged with Boston Scientific in April 2006.
A capacitor in the affected devices could malfunction, leading to premature battery depletion.
As of March 30, 2007, Boston Scientific has confirmed 19 field events with Guidant’s devices, mostly related to premature battery depletion. There were no serious injuries or deaths reported.
FDA is aware that this news may cause patients to be concerned. The chance that a given patient is affected by this problem is very small. However, FDA will make sure patients have access to new information as it becomes available.
Patients who are unsure if they have a device affected by this recall should:
Patients who have a device affected by this recall should consult with their physician on the next steps to take. A patient’s physician is in the best position to help decide what is best because physicians receive current information on these devices and also have access to the individual patient’s medical history.
No. In most cases, routine follow-up is all that will be required. In some cases, more frequent device checks may be advised. Only in rare cases, will a device need to be removed prematurely from a patient.
If a patient has a device with a degraded capacitor, the time from implant to 2.65 volts (Middle of Life 2 / MOL2) will be reduced. To determine whether a patient may be at risk for a reduced ERI to EOL time, it is important to note when 2.65 volts (MOL2) was observed. For each patient:
Note: In geographies where available, the LATITUDE® Patient Management System can facilitate patient monitoring and also provide automatic notification when the device reaches a battery status of ERI.
FDA is committed to immediately providing all important risk information we receive, as soon as we receive it. Physician feedback is very valuable to us. Please tell us what you are seeing and any concerns you have.
Guidant Corporation merged with Boston Scientific Corporation on April 24, 2006. Guidant Corporation became the Cardiac Rhythm Management division of Boston Scientific Corporation. The products being recall are labeled with the Guidant name.
Boston Scientific notified FDA about the problem with these devices on March 23, 2007. On April 5, Boston Scientific issued a product advisory to physicians to alert them to the problem with the Guidant ICDs and CRT-Ds listed above and provide recommendations for patient treatment.
FDA has determined that the product advisory constitutes a recall. FDA will be monitoring the recall to ensure that the firm’s actions are adequate to protect the public. FDA will ensure that information for patient care is made available. Information about the recall, and any updates, will be posted on FDA’s website
The May 2006 recall involved problems with a faulty capacitor from the firm’s supplier. While the company’s current recall also deals with a faulty capacitor from the supplier, the failure modes and patient outcomes differ from those described in the May 2006 recall. Therefore, the current recall is being treated as a new recall and not as an extension of the May 2006 recall.
FDA’s December 2006 inspection of Guidant indicated that the GMP issues previously cited by FDA appeared to have been adequately addressed. However, a GMP inspection evaluates a company’s systems at one point in time only and cannot necessarily predict how these systems will perform in the future. Therefore FDA will continue to look at individual Guidant products and recall patterns to ensure that quality systems remain in place to identify and address any problems that may occur in the future. FDA’s Quality System regulation requires firms to identify device problems both before and after distribution. When a problem is discovered, the firm must conduct an investigation commensurate with the significance and risk of the problem. These investigations can determine whether there is a problem, the extent of the problem, and how best to address it. This determination can be viewed as a Quality System that is working as intended.
Updated April 10, 2007
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