Terumo Cardiovascular Systems Issues Urgent, Nationwide/Worldwide Recall of Pediatric Arterial Cannulae Lawsuit
Terumo Cardiovascular Systems (Terumo CVS) are manufacturers of products that are required for specialized needs of the cardiac surgical teams for cardiopulmonary bypass and intra-operative monitoring. They develop and introduce new cannulae to address the needs of cardiac surgeons and are a trusted brand by many. One of their latest products is the Tenderflow Pediatric Arterial Cannulae that is required during heart bypass surgery.And now the subject of lawsuits.
What is a cannula?
A cannula is used by cardiac surgeons during cardiac bypass surgeries. It is a disposable tube that is inserted into the aorta during the procedure. The purpose is to perfuse the ascending aorta. Another equipment needed during the procedure is the ‘introducer’. The introducer is needed for smooth progress during insertion of the cannula and to stabilize the device. The introducer is subsequently removed. If the doctor experiences any difficulty in drawing back the cannula then it has to be removed and replaced. However, the risk involved here is that of aortic damage or blood loss which may sometimes be fatal.
What are the risk involved and why the recall has been necessitated?
Terumo Pediatric Arterial Cannulae were distributed to 68 hospitals throughout United States. It was also distributed to distribution centers in Australia, Canada and Europe. The company had received reports from at least five doctors regarding difficulty in it usage. The risk involved is a cause of concern. If they are unable to retract the introducer smoothly then it may cause serious injury to some of their patients which may turn out to be life threatening. There have been no reports of patient injuries or death caused by this malfunction. This has been the subject of lawsuits.
Considering the serious nature of the problem, the company decided to voluntarily recall its Tenderflow Pediatric Arterial Cannulae from the 21 lot codes that had been sent to the hospitals. A letter informing the hospitals had been sent on October 16, 2008. The company also notified them not to use the product unless it is medically necessary. Moreover, the company has recommended them to use the cannula without the introducer in situations where it is extremely necessary to do so.
The company has also informed the US Food and Drug Administration about the recall. A firm press release to this effect has been released by the FDA dated December 01, 2008. Customers need not worry as the recall has been issued and it is limited to the 21 lot codes only that have been mentioned in the FDA release. It is important to note that though there have been reports of problems faced there have been no life threatening injuries to patients.