| Subject: | FDA Announces Guidant's Class I Pacemaker Recall |
| Category: | Food and Drug Administration (FDA)
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| Published: | Fri, 5 Aug 2005 - 10:00 am |
| The FDA is notifying healthcare providers and patients that Guidant Corporation is voluntarily recalling certain pacemakers. A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death. The FDA has... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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