Device product
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.
Z-2552-2016
Product summary
- Event
- Event 74781
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 units
- Official record key
device-enforcement:Z-2552-2016
Official wording
Reason: Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. The possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.
Code information: 160317-001, 160371-002, 160317-003, 160324-010.
Distribution pattern: US: Distribution to the states of : NY, OH and CA.
Derived failure modes
-
Manufacturing or process control
error during manufacturing