| Subject: | Medtronic Suspends Distribution of Sprint Fidelis Defibrillation Leads |
| Category: | Food and Drug Administration (FDA)
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| Published: | Wed, 17 Oct 2007 - 10:00 am |
| Medtronic has announced that it has voluntarily suspended distribution of its Sprint Fidelis defibrillation leads (model numbers 6930, 6931, 6948, 6949) because a small number of lead fractures have been detected. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Medtronic first notified physicians in March about the fracture rate at that time and the proper... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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