On June 17, 2005, the FDA issued a recall for certain Guidant
defibrillator models. This Guidant recall is for both the Guidant
implanted cardioverter defibrillator (ICD) and cardiac
resynchronization therapy (CRT) devices. Although these devices are
technically different, pacemakers and defibrillators both regulate
heart rate/rhythm control.
On July 28, 2005, the company warned doctors that
a defect in approximately 28,000 pacemakers still in use by patients
may need to be replaced. Warnings on additional pacemakers were made on
September 22, 2005, when Guidant Corp. announced that the Insignia and
Nexus devices can also experience a sudden loss of pacing.
Guidant Corporation is recalling the following ICDs:
- Insignia
- Nexus
- Contak Renewal
- Contak Renewal 2
- Contak Renewal TR and TR2
- Ventak Prizm AVT
- Ventak Prizm 2 and Prism 2 DR
- Vitality
- Vitality 2
- Vitality AVT
- Renewal AVT
- Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RFs