band recall
VOLUNTARY RECALL OF REALIZE® ADJUSTABLE GASTRIC BAND
CINCINNATI - October 13, 2010 - Obtech Medical Sàrl, a medical device manufacturer, and Ethicon Endo-Surgery (EES), in cooperation with the U.S. Food and Drug Administration (FDA), have initiated a voluntary worldwide recall of existing inventory of adjustable gastric band systems sold under the brand name: REALIZE® Adjustable Gastric Bands. There is no action required for patients who already have received these gastric bands, and removal (explantation) of the gastric band is not required.
The voluntary recall was undertaken due to reports of the potential for the Tubing Strain Relief, a small (2 centimeter) flexible sheath on the band's Injection Port, to slide out of its intended position. In these rare cases, the Tubing Strain Relief may slide along the catheter tubing that connects to the Injection Port. If this happens, the Tubing Strain Relief can no longer aid in preventing kinking where the tubing connects to the port. The Tubing Strain Relief was an enhancement made to the gastric band system to address tube kinking, a complication common to all gastric bands.
Movement of the Tubing Strain Relief is highly unlikely to cause any serious injury or adverse health consequences and it rarely affects the band's function. In the extremely rare instance when tube kinking occurs at the Injection Port, the physician might be unable to adjust fluid volume within the gastric band, which may require additional surgery to correct. The reported incidence of the Tubing Strain Relief sliding out of its intended position is less than 1 in 1,000. The reported incidence of tube kinking at the port related to the Tubing Strain Relief sliding out of position is 1 in 10,000. There have been no reported cases of gastric band removal due to the Tubing Strain Relief sliding out of position.
As part of our ongoing commitment to improve the safety and effectiveness of the band, EES identified this issue as part of the company's continuous improvement program and developed an enhanced design of the component that was approved by the FDA. Hospitals and clinics will receive the enhanced replacement product upon returning the recalled product. All new orders will receive the updated product.
About the Realize® Adjustable Gastric Band
The Realize® Adjustable Gastric Band is used in one type of weight-loss surgery. It contains two main components: the first is a fluid-filled balloon that is placed around the stomach; the second is an injection port to adjust the degree of fluid in the band. Thin flexible tubing connects these two main components. The recall involves an ancillary component called the Tubing Strain Relief.
If surgeons or patients have any additional questions, they may call our Customer Support Center at 1-866-REALIZE (1-866-732-5493) for more information.
About Ethicon Endo-Surgery
Ethicon Endo-Surgery develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information can be found at www.ethiconendosurgery.com.
6-7-13 band removed. No revision. Facebook Failed Lapbands and Realize Bands group and WLS-Support for Regain and Revision Group
