| Subject: | Class I Recall of Transseptal Sheath Introducer Kit (also under the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit) |
| Category: | Food and Drug Administration (FDA)
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| Published: | Fri, 5 Mar 2010 - 02:00 pm |
| Audience: Cardiologists, Hospital Risk Managers The Food and Drug Administration (FDA) and Thomas Medical Products have notified healthcare professionals of a Class I recall of the Transseptal Sheath Introducer Kit (also under the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding Introducer Kit), which is a prescription medical device used to pass heart catheters from the right to the left side of the heart. The recall was initiated because the sheath tip may break off and... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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