Terumo Pediatric Arterial Cannulae Recall: Heart Bypass Device May Fail

Terumo Cardiovascular Systems (Terumo CVS) has issued an urgent, worldwide recall of its Tenderflow Pediatric Arterial Cannulae, which is used during heart bypass surgery.

The cannula recall was issued after the company received at least five reports of doctors who experienced difficulty retracting the introducer, which could lead to serious and potentially life-threatening injury.

A cannula is a disposable tube which may be inserted into the aorta during cardiac bypass surgery to perfuse the ascending aorta. The introducer is used to facilitate the insertion of the cannula and to stabilize the device as it enters.

The introducer is subsequently removed. However, if a doctor experiences difficulty retracting the introducer, the cannula must be removed and replaced. This could cause aortic damage, blood loss or possibly lead to death.

The recalled Terumo Pediatric Arterial Cannulae was distributed to 68 hospitals throughout the United States.

According to a press release announcing the recall, all of the hospitals were notified by letter on October 16, 2008 not to use the product unless medically necessary. In those cases where it must be used, the company has recommended that the cannnula be used without the introducer.

Although at least five reports of complications with the Tenderflow Pediatriac Arterial Cannulae have been reported, Terumo CVS indicates that they are unaware of any reports of patient injury or death caused by the malfunction.

The recall applies to 21 different lot codes, including: Catalog No. 813568 with Lot Nos. 0501639, 0512002; Catalog No. 813567 with Lot Nos. 0501557, 0512008; Catalog No. 813570 with Lot Nos. 0502200, 0513069; Catalog No. 813569 with Lot Nos. 0502199, 0513068, 0517852; Catalog No. 813572 with Lot Nos. 0507121, 0512918; Catalog No. 813571 with Lot Nos. 0507120, 0512919, 0518680; Catalog No. 813574 with Lot No. 0509240; Catalog No. 813573 with Lot Nos. 0509238, 0517874; Catalog No. 813576 with Lot No. 0509241; Catalog No. 813575 with Lot Nos. 0500759, 0513331; Catalog No. 813578 with Lot No. 0500760 and Catalog No. 813577 with Lot No. 0502878.