June 17, 2005—Guidant Corp. announced that nearly 50,000 heart defibrillators would
be recalled as a result of design flaws that render the devices ineffective. The design defects
could cause the device to malfunction, risking serious injury in those implanted with the defibrillators.
The recall was extended one week later to include additional models.
The company revealed at the time that it was aware of at least 45 reports of failures, 2 of
those leading to death. Guidant indicated it may need to replace as many as 28,900 defibrillators
already implanted in patients. Another 21,000 can be reprogrammed to correct the flaw.
The affected devices are:
- Guidant Ventak Prizm 2 DR
- Guidant Contak Renewal
- Guidant Contak Renewal 2
- Guidant Contak Renewal 3
- Guidant Contak Renewal 4
- Guidant Ventak Prizm AVT
- Guidant Vitality AVT
- Guidant Renewal 3 AVT
- Guidant Renewal 4 AVT
- Guidant Renewal RF
Guidant Corp. is recommending that those patients relying on the above devices discuss corrective
options with their physicians. |