FDA Device

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.

Hazard

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.

What You Should Do

Remedy

A Dear Doctor letter dated May 4, 2016, was sent to all the customers to inform them that ReShape Medical is recalling ReShape Integrated Dual Balloon System, Gen 1 due to a suspected misalignment of the connection between the proximal balloon cap and the delivery catheter. The letter informs the customers that 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. Customers are informed of the planned field correction and if customers have any questions then they're instructed to contact ReShape Medical Customer Service at (844) 937-7374. For further questions please call (949) 429-6680 ext. 106

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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 die
Brand
Reshape Medical Inc 100 Calle Iglesia San
UPC
160317-001, 160371-002, 160317-003, 160324-010.

Units Affected

56 units

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