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Guidant Issues Advisory on Early ICD Battery Depletion
from Heartwire — a professional news service of WebMD

Steve Stiles



April 11, 2007 (St Paul, MN) - The Boston Scientific division Guidant is warning physicians and patients [1,2] that some models of its Vitality, Vitality 2, and Contak Renewal 3 and 4 lines of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices may require early replacement due to premature battery depletion [3].

The problem, which is caused by "low-voltage capacitors from a former supplier," could potentially cut the interval between the elective replacement indicator and the battery's end of life to less than three months, according to the company. It cites 19 confirmed cases of the early battery depletion, out of about 73 000 devices in use worldwide, and says no one has died or been seriously injured as a result of the problem.

Guidant's safety advisory, which the FDA has classified a "recall"[4] and which lists the specific models involved and provides guidelines for following patients now using them, says they have been withdrawn from distribution and are being retrieved from hospital shelves.

Boston Scientific. Product advisory--Potential for reduced ERI to EOL time due to low-voltage capacitor degradation in a subset of ICDs and CRT-Ds [letter to physicians]. April 5, 2007. Available at:

http://www.guidant.com/physician_communications/A_ShortenedReplacementWindow.pdf.
Boston Scientific Product advisory letter [letter to patients]. April 5, 2007. Available at: http://www.guidant.com/patient/communication/AP_Shortened_Replacement_Window.pdf.
Guidant. Safety advisory. April 5, 2007. Available at: http://www.guidant.com/ppr/advis/2007_04_05.shtml.
Food and Drug Administration. Boston Scientific / Guidant recall: Questions & answers. April 10, 2007. Available at: http://www.fda.gov/cdrh/news/guidantrecall.html.
The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.


4 Comments

Thank you Smitty

by $6Mman - 2007-04-17 06:04:03

I heard it here first! I haven't received any notification, well not yet, from Guidant. Thankfully, I do not believe I will be affected as the implant is for demand and not pacing me. Thanks just the same to you, Smitty, and others who see these alerts. Another benefit of being a member of the club! You hear it here first!! Be well.
~Adam

Another thank you

by amymarla - 2007-04-17 08:04:05

I too heard here first! Can't thank you enough for passing this information on to us. Please keep up the watchful eye. AmyMarla

Guidant Still Can't Get It Right

by ted - 2007-04-18 02:04:45

It seems that Guidant just can't get it together. It amazes me that any reputable doctor would implant a Guidant product in a patient without first disclosing Guidant's sordid history of failure. No patient in their right mind would accept a Guidant if he/she knew all the facts. At least Boston Scientific is not hiding the truth as Guidant did in the past. Ted

guidant recall

by teen - 2007-05-15 06:05:23

i am really worried now! my son has just been fitted with a guidant 4 weeks ago. we are just getting over the worry of him getting a pm and after reading this, i don't know what to think.
it's all so new to us.

teen.

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