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.

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Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.