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U.S. Department of Health and Human Services

Class 2 Device Recall ReShape Integrated Dual Balloon System, Gen 1

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  Class 2 Device Recall ReShape Integrated Dual Balloon System, Gen 1 see related information
Date Initiated by Firm May 04, 2016
Create Date August 17, 2016
Recall Status1 Terminated 3 on August 17, 2016
Recall Number Z-2552-2016
Recall Event ID 74781
PMA Number P140012S002 
Product Classification Implant, intragastric for morbid obesity - Product Code LTI
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.
Code Information 160317-001, 160371-002, 160317-003, 160324-010.
Recalling Firm/
Manufacturer		 Reshape Medical Inc
100 Calle Iglesia
San Clemente CA 92672-7502
For Additional Information Contact
949-429-6680 Ext. 106
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action 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
Quantity in Commerce 56 units
Distribution US: Distribution to the states of : NY, OH and CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LTI and Original Applicant = Boston Scientific Corporation
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