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Shortened Battery Life Forces Recall of 73,000 Implantable Defibrillators
ROCKVILLE, Md. -- Guidant has recalled approximately 73,000 implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) because of a defect that shortened battery life, the FDA reported.
ROCKVILLE, Md., April 11 -- Guidant has recalled approximately 73,000 implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) because of a defect that shortened battery life, the FDA reported.
In a product advisory to physicians, the company said the recalled devices have faulty capacitors, which caused rapid depletion of batteries. The company was purchased by Boston Scientific a year ago
In some devices the time between elective replacement indicator and end of life was less than three months instead of more than two years, the company added. Nineteen of the 73,000 recalled devices have been "confirmed to have accelerated battery depletion, which could have resulted in the shortened elective replacement indicator to end of life time."
The company said there were no patient deaths or serious injuries because of the device defects.
In 2005 Guidant was plagued by serial recalls-a total of five separate recalls issued from June through September.
The newly recalled devices 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).
The recommendations from Guidant included:
- Review patient records to assess battery voltage.
- If battery voltage is above 2.65 volts (MOL2), continue to follow patient every three month per device labeling.
- If battery voltage is at or below 2.65 volts (MOL2), determine the time between device implant and this observation.
- If time from implant to 2.65 volts (MOL2) is greater than 27 months (Note: for Vitality EL/ 2 EL/HE devices the time value is 32 months) the patient is not at risk for shortened ERI to EOL time and the advisory no longer applies.
- If time from implant to 2.65 volts (MOL2) is 27 months or less (Note for vitality EL/2 EL/HE devices, this value is 32 months) the patient should be followed monthly until elective replacement indicator. For devices that require monthly follow-up, replace the device within 30 days after elective replacement indicator is displayed as elective replacement indicator to end of life time may be shortened.
The FDA pointed out that chance that a given patient is affected by this problem is extremely small.
