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U.S. Department of Health and Human Services

Class 2 Device Recall ReShape

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  Class 2 Device Recall ReShape see related information
Date Initiated by Firm October 14, 2016
Date Posted November 10, 2016
Recall Status1 Terminated 3 on January 24, 2017
Recall Number Z-0392-2017
Recall Event ID 75475
PMA Number P140012S002 
Product Classification Implant, intragastric for morbid obesity - Product Code LTI
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) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
Code Information Lot Number Expiration Date 160815-001 2018-08-07 160816-001 2018-08-07 160824-003 2018-08-18 160825-001 2018-08-18 160825-002 2018-08-18
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		 ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.
FDA Determined
Cause 2		 Device Design
Action ReShape sent a customer notification letter dated October 14, 2016 was sent to customers to inform them that ReShape Medical is recalling the Integrated Dual Balloon System due to customer reports of instillation fluid leaking during the device inflation procedure. The letter informs the customers that any instillation fluid leakage during the inflation process will cause an incomplete balloon fill and require immediate removal of the device. Customers are instructed to contact ReShape Medical Customer Service at (844) 9377374 for any questions related to the product returns.
Quantity in Commerce 114 units
Distribution US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL
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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