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Thomas Medical Products recalls sheath introducer kits
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Thomas Medical Products has announced a class I recall for its Transseptal Sheath Introducer Kit, citing concerns about increased risk for device breakage.
The recall was initiated on Feb. 1, 2010 and applies to all devices manufactured and distributed from Oct. 1, 2006 to Dec. 27, 2009. The products included in the recall can also be identified under the trade names HeartSpan, CHANNEL FX, Torflex and Braided Guiding Introducer Kit.
The sheaths are used to assist in the passage of catheters through the septum. According to an FDA press release, a malfunction that increases the risk for breakage in the sheath tips thereby increasing the risk for embolization spurred the recall. So far five adverse event reports have been associated with the introducer kits, the company stated in a press release.
Thomas Medical Products sent notices to its distributors requesting they cease distribution of the device and also asked that all unused devices be returned to the manufacturer. A complete listing of the affected lot and catalog numbers is available at the General Electric website.