Teleflex initiated the recall in February, 2016 for 47,140 units distributed to hospitals, clinics, and medical centers throughout the United States and globally. The Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits are being recalled because the sheath body may separate from the sheath hub during insertion. If separation occurs, the patient may bleed from the sheath. Significant blood loss may occur, and the patient may also experience interruption or loss of intra-aortic balloon pump treatment.
The Food and Administration (FDA) explains that the Intra-Aortic Balloon Catheter is designed to provide cardiac assist for patients with failing hearts and/or insufficient blood flow through the coronary arteries who are not responding to medical therapy. The IAB is inserted through the femoral artery (in the thigh) into the aorta using an elongated Teflon cover (sheath) used to dilate the incision of the artery. The balloon catheter assists circulation by inflating and deflating the balloon to the patient’s heartbeat.
Class I Recall for Intra-Aortic Balloon Catheters
The FDA has designated this recall a Class I recall, the most serious category, reserved for situations where there is a reasonable probability that use of the device can result in serious health consequences or death. At the time of the recall, there were 13 adverse events reports, including six serious injuries and one death.
The recall notice was posted on the FDA web site; the notice gives the affected produce codes and lot numbers. Teleflex notified distributors and customers through an Urgent Medical Device recall letter on February 11, 2016. Teleflex advises health care facilities that have affected catheters and insertion kits to immediately discontinue using them and return them to Teleflex.
The FDA encourages doctors, other health care professionals, and patients to report adverse events or side effects related to these devices to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
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