Recall of SAGB Swedish Adjustable Gastric Band including Velocity™ Injection Port and Applier (BD2XV and BD23XV)

Ethicon Endo-Surgery, is initiating a voluntary recall of the SAGB Quick Close Swedish Adjustable Gastric Band including Velocity™ Injection Port and Applier and the SAGB VC Swedish Adjustable Gastric Band including Velocity™ Injection Port. The recall of the Swedish Adjustable gastric band is due to reports of the band's Strain Relief sliding out of its intended position. When this happens, the Strain Relief no longer aids in preventing kinking at the point where the tubing connects to the port. If the catheter tube becomes separated from the Injection Port, it is possible that there could be saline leakage through the tubing and the Strain Relief component could become a free foreign body within the abdomen, which may require additional surgical intervention. Surgeons are recommended to check for the patency of the tube and positioning of the Strain Relief component in existing patients.
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

24 Feb 2021

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP). HPP is a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg/, and follow the procedures below to access the MOH Alert system.

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.