Recall Z-0392-2017— Reshape Medical Inc
Class II · Terminated
Class II FDA medical device recall by Reshape Medical Inc, initiated 2016-10-14, terminated 2017-01-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation..
- Recalling firm
- Reshape Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-14
- Terminated
- 2017-01-24
- Firm location
- San Clemente, CA, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.