Reshape Medical Recalls Integrated Dual Balloon System Due to Fluid Leak Risk
Reshape Medical is recalling 114 units of the Integrated Dual Balloon System Gen 1 because distillation fluid may leak during inflation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential leak of fluid during a medical procedure. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Reshape Medical Inc. is recalling 114 units of the ReShape Integrated Dual Balloon System, Gen 1 (Model No. 01-0013-001, Catalog No. RSM110). The recall is due to the potential leak of distillation fluid during balloon inflation.
The affected devices were distributed nationwide in the United States, specifically in the states of Missouri, Texas, Arizona, California, New York, Tennessee, Georgia, Louisiana, Florida, Massachusetts, Ohio, Indiana, and Illinois. The recall covers specific lot numbers with expiration dates ranging from August 7, 2018, to August 18, 2018.
The ReShape Integrated Dual Balloon System is indicated for weight reduction in obese patients with a Body Mass Index (BMI) of 30-40 kg/m2 and one or more obesity-related comorbid conditions. Patients who have received this device should contact their healthcare provider for instructions on next steps.
The recalled product
- 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)
- Manufacturer
- Reshape Medical Inc
- Hazard
- Affected units
- 114
Distribution
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