Life Sciences

Terumo Cardiovascular Systems recalls pediatric arterial cannulae

Device Regulation Alert: Safety, Compliance and Reimbursement News, December 15, 2008

Terumo Cardiovascular Systems issued a Class I recall for 21 lots of its Tenderflow Pediatric Arterial Cannulae, according to a company press release.

An arterial cannula is a disposable tube inserted in the aorta during cardiac bypass surgery. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.

Terumo received five reports of difficulty retracting the introducer from the cannula, but no patient injuries or deaths have been associated with the product. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, which may lead to aortic damage, blood loss, and death.

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