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U.S. Department of Health and Human Services

Safety

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Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae

Audience: Cardiological healthcare professionals, hospital risk managers

[Posted 12/08/2008] Terumo Cardiovascular Systems notified healthcare professionals of a worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes (see Terumo press release for complete list). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death. Healthcare professionals are advised to not use the product unless medically necessary. In those cases, the cannula should be used without the introducer.

[December 01, 2008 - Press Release - Terumo Cardiovascular Systems]