Terumo Cardiovascular Systems Pediatric Arterial Cannulae recalled for complications that could lead to aortic damage, blood loss and/or death
Terumo Cardiovascular Systems (Terumo CVS) has issued an urgent worldwide recall of its Tenderflow™ Pediatric Arterial Cannulae, a defective medical device, involving 21 lot codes (see information below). 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.
Tenderflow™ Pediatric Arterial Cannula Catalog and Lot Numbers Affected
|
Catalog Number |
Lot Number |
|
813568 |
0501639, 0512002 |
|
813567 |
0501557, 0512008 |
|
813570 |
0502200, 0513069 |
|
813569 |
0502199, 0513068, 0517852 |
|
813572 |
0507121, 0512918 |
|
813571 |
0507120, 0512919, 0518680 |
|
813574 |
0509240 |
|
813573 |
0509238, 0517874 |
|
813576 |
0509241 |
|
813575 |
0500759, 0513331 |
|
813578 |
0500760 |
|
813577 |
0502878 |
When and how is the device used?
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.
Where was the defective device distributed?
Terumo Cardiovascular Systems Corporation is a global manufacturer and marketer of medical devices for cardiac and vascular surgery. Terumo CVS distributed this product directly to 68 U.S. hospitals, and has notified all of the hospitals of the voluntary recall in a letter dated Oct. 16, 2008. The product was also distributed from distribution centers in Australia, Canada and Europe.
Terumo recalls the defective medical device
Terumo informed the U.S. Food and Drug Administration of this recall. The notification letter recommended that customers not use the product unless it is medically necessary.
Injured by the Terumo Arterial Cannula?
If you or a loved one have been injured by this dangerous medical device, you may be entitled to compensation from those responsible. Medical device manufacturers have an obligation to manufacture and distribute safe products. When they fail to do this, a medical injury lawyer can hold them accountable. If you have questions, contact a medical injury lawyer today for a free initial consultation. We can help you understand your options for claiming compensation.
