Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ReShape Integrated Dual Balloon System Recalled by Reshape Medical Inc Due to Due to a suspected misalignment of the connection...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Reshape Medical Inc directly.
Affected Products
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.
Quantity: 56 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 3 states: CA, NY, OH
About Reshape Medical Inc
Reshape Medical Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report