Recall Z-2552-2016— Reshape Medical Inc
Class II · Terminated
Class II FDA medical device recall by Reshape Medical Inc, initiated 2016-05-04, terminated 2016-08-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Reshape Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-04
- Terminated
- 2016-08-17
- Firm location
- San Clemente, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.