Drugs & Medical Devices Law
What defibrillator models are being recalled?
The Guidant defibrillators affected by this recall are:
• PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
• CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
• CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
Guidant also recently informed the FDA that they are recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company reports the devices are subject to a memory error, which may affect therapy and device performance.