Z-2552-2016 Class II Terminated
FDA device recall Z-2552-2016 was initiated by Reshape Medical Inc on May 4, 2016 and is designated Class II. Reason for recall: 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 manufa… The recall status is terminated (terminated August 17, 2016). Affected quantity: 56 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2016
- Initiation Date
- May 4, 2016
- Termination Date
- August 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US: Distribution to the states of : NY, OH and CA.
Code Information
160317-001, 160371-002, 160317-003, 160324-010.