Guidant FDA Safety Warnings and Communications
The purpose of the Guidant FDA safety warnings and communications is to advise the physicians and patients
about specific malfunctions with the Guidant products and devices that have already harmed or could potentially harm patients.
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On Oct. 15, 2007, Medtronic suspended all sales of Sprint Fidelis leads. Please click here to read more about the Medtronic recall. |
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Guidant is required by the FDA (United States Food and Drug Administration) to offer these types of warnings and communications
when they learn of a product defect so that physicians and patients may take the steps necessary to offset potentially harmful events
related to the defective Guidant product.
Guidant Recall – June 17, 2005
On June 17, 2005 Guidant issued a communication related to defects in several of their implantable cardioverter defibrillators (ICD)
and cardiac resynchronization therapy devices (CRT). The FDA has classified this
communication as a Guidant recall.
The defective product devices listed in the June 17 Guidant communication included:
- VENTAK PRIZM 2DR (Model 1861). ICDs manufactured on or before April 16, 2002.
- CONTAK RENEWAL (Model H135) and CONTAK RENEWAL 2 (Model H155) CRT Devices
manufactured on or before August 26, 2004.
- VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT ICDs (all series numbers).
For the VENTAK PRIZM and CONTAK RENEWAL devices, the nature of the defect is the deterioration of a wire lead,
which when combined with other factors, results in the inability to deliver treatment. This Guidant recall related defect is
known to be responsible for 43 product failures. Two of these Guidant product failures resulted in patient deaths.
The VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT have a defect related to a
memory error, which renders the devices unable to deliver certain types of therapy. According to the company, two incidences
of failure have been reported related to the Guidant recall defect, but neither incident caused injury or death.
Physicians were instructed to discontinue implanting these devices and contact their patients who received these devices.
Although a change has not yet been made as of October 3, 2006, the FDA is in the process of softening its rhetoric with regard to
cardiovascular medical device malfunctions. As opposed to the current label of "recall," the FDA is exploring
other phrases that could serve the purpose of warning without striking unnecessary concern into the minds of the
hundreds of thousands of patients implanted with a pacemaker or ICD. The FDA has been working in conjunction with
the Heart Rhythm Society to make a number of changes designed to improve awareness of cardiovascular device malfunctions
while simultaneously protecting all aspects of patient welfare.
Guidant Communication – June 24, 2005
On June 24, 2005 Guidant issued a communication related to defects in several of their defective products. These products include
devices for cardiac resynchronization therapy (CDT). The defective products listed in the communication include:
- CONTAK RENEWAL 3 and 4
- RENEWAL 3 and 4 AVT
- RENEWAL RF
The defect with these products includes a magnetic switch that could become stuck in the open position.
This defective magnetic switch can then inhibit the device's ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion.
Physicians have been instructed to discontinue implanting these devices and contact their patients who received these devices.
Boston Scientific Issues Recall of Guidant
Devices – June 26, 2006
Boston Scientific Corp. purchased its troubled rival in April 2006 for $28 billion, assuming its liabilities.
Read more about the Boston Scientific purchase of Guidant Corp.
In an effort to stymie any further litigation, Boston Scientific has taken a proactive approach to notifying
physicians and patients of potentially defective Guidant devices. This most recent recall affects an additional
six device models, including:
- Vitality defibrillators
- Vitality 2 defibrillators
- Ventak Prizm 2 defibrillators
- Contak Renewal TR/TR2 CRTs
- Insignia pacemakers
- Nexus pacemakers
Patients implanted with any of the aforementioned devices are advised to consult with their physician to determine an appropriate course of action.
Guidant Recall Update – April 11, 2007
Guidant Corp. has issued another recall of some 73,000 potentially defective ICD and CRT devices. A battery defect causing the
rapid depletion of battery life has been determined the causative factor in the April, 2007 Guidant recall. Device batteries designed
to last a minimum of two years were failing after as little as three months. Of the 73,000 (+) devices involved in the recall,
19 defective models have been found. Although no serious injuries or deaths have been reported as a result of the defects,
Guidant felt the recall was a prudent measure designed to avoid any such incident.
About the Sponsors of this Pacemaker and Defibrillator Information Website
If you or a loved one has been injured due to a defective pacemaker or defibrillator product manufactured by Guidant, you
may be entitled to compensation. The sponsors of this website are attorneys who specialize in helping those who have been injured
by defective products. Please contact our offices today so that one of our Guidant lawyers may answer any questions that you
have and provide a free case review if needed. Our toll-free number is 888-255-AWKO (2956).
If warranted, we can file a Guidant lawsuit to help obtain the proper compensation.
The sponsors of this website include: Aylstock, Witkin & Sasser, Guidant Litigation Group; Neblett, Beard & Arsenault;
Andrus, Boudreaux, Lemoine & Tonore; Lundy & Davis, LLP; and Barrios, Kingsdorf & Casteix, LLP.
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