Reshape Medical Inc: Medical Device Recall in 2016 - (Recall #: Z-2552-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 4, 2016

Date Posted: August 24, 2016

Recall Number: Z-2552-2016

Event ID: 74781

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.

Status: Terminated

Product Quantity: 56 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated