Terumo CVS Recalls Tenderflow Pediatric Arterial CannulaeDec 8, 2008 | Parker Waichman LLP
Terumo Cardiovascular Systems is issuing an urgent recall for its Tenderflow Pediatric Arterial Cannulae. According to the Food & Drug Administration (FDA), the recall was issued after Terumo received five reports of difficulty retracting the introducer from the cannula.
An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.
According to the recall notice, when the introducer cannot be retracted from the Tenderflow Pediatric Arterial Cannulae, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death. According to the FDA, there have been no reports of patient injury or death associated with the defective Tenderflow Pediatric Arterial Cannulae.
The Tenderflow Pediatric Arterial Cannulae recall involves the following catalog and lot numbers:
Catalog Number Lot Number
Catalog #813568 Lot #s 0501639, 0512002
Catalog #813567 Lot #s 0501557, 0512008
Catalog #813570 Lot #s 0502200, 0513069
Catalog #813569 Lot #s 0502199, 0513068, 0517852
Catalog #813572 Lot #s 0507121, 0512918
Catalog #813571 Lot #s 0507120, 0512919, 0518680
Catalog #813574 Lot #s 0509240
Catalog #813573 Lot #s 0509238, 0517874
Catalog #813576 Lot #s 0509241
Catalog #813575 Lot #s 0500759, 0513331
Catalog #813578 Lot #s 0500760
Catalog #813577 Lot #s 0502878
Terumo said the recalled Pediatric Arterial Cannulae were directly distributed to 68 U.S. hospitals, and all of the hospitals were notified of the voluntary recall in a letter dated Oct. 16, 2008. The notification letter recommended that customers not use the product unless medically necessary. In those cases, the cannula should be used without the introducer.
For more information clinicians within the U.S. may contact Terumo at 800-521-2818, Monday-Friday from 8:00 a.m. to 5:00 p.m. EST.