Device Recall ReShape Integrated Dual Balloon System, Gen 1

160317-001, 160371-002, 160317-003, 160324-010.

Gastroenterology-Urology Devices

3

Yes

US: Distribution to the states of : NY, OH and CA.

ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 || The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.