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Terminated

ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: 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 obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

FDA Recall Z-0392-2017 · Posted 2016-11-10

Recalling FirmReshape Medical Inc
Recall StatusTerminated
Product CodeLTI
Date Initiated2016-10-14
Date Terminated2017-01-24
Product Quantity114 units

Reason for Recall

ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.

Firm Action

ReShape sent a customer notification letter dated October 14, 2016 was sent to customers to inform them that ReShape Medical is recalling the Integrated Dual Balloon System due to customer reports of instillation fluid leaking during the device inflation procedure. The letter informs the customers that any instillation fluid leakage during the inflation process will cause an incomplete balloon fill and require immediate removal of the device. Customers are instructed to contact ReShape Medical Customer Service at (844) 9377374 for any questions related to the product returns.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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