Recall Information on Guidant Ventak Prizm 2 DR (model 1861)
| Issue |
| The device can short-circuit due to deterioration in a wire insulator, causing a failure of the device. |
| Injuries |
| Guidant Corp. reported that it had received 28 reports of failures worldwide affecting this model. |
| Affected Models |
|
The problem occurs in model 1861 units, manufactured before April 16, 2002. The devices recalled may be specific to certain serial numbers and/or manufactured dates. |
| Recommendation |
| Patients with this device should contact their physicians to discuss possible removal of the device. |
| Guidant Communications |
|
The following information is provided by Guidant Corporation.
|
- Contak Renewal
- Contak Renewal 2
- Contak Renewal 3
- Contak Renewal 3 AVT
- Contak Renewal 3 CRT-D
- Contak Renewal 3 HE CRT-D
- Contak Renewal 4
- Contak Renewal 4 AVT
- Contak TR
- Discovery
- Discovery II
- Insignia
- Intelis II
- Meridian
- Nexus
- Pulsar
- Pulsar Max II
- Renewal 3 AVT
- Renewal 4 AVT
- Renewal RF
- Ventak Prizm 2 DR
- Ventak Prizm AVT
- Virtus Plus II
- Vitality 2 DR
- Vitality 2 VR
- Vitality AVT
- Vitality DS DR
- Vitality EL DR
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