Class 2 Device Recall Obalon Balloon System with 4300 Touch Dispenser

• Date Initiated by Firm: May 23, 2019
• Create Date: April 28, 2020
• Recall Status: Completed
• Recall Number: Z-1805-2020
• Recall Event ID: 85050
• PMA Number: P160001S020 P160001S007
• Product Classification: Implant, intragastric for morbid obesity - Product Code LTI
• Product: Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.
• Code Information: ObalonR Balloon System with Navigation and Touch. UDI: 00859810006104; Model No.: Model 4300 Touch Dispenser;Software version 02.00.00.0076. Serial Numbers: 0097, 0076, 0077, 0078, 0079, 0080, 0082, 0083, 0084, 0085, 0086, 0087 0088, 0089, 0090, 0091, 0092, 0093, 0094, 0095, 0097, 0099, 0100, 0101, 0102, 0103, 0104, 0106, 0107, 0109, 0111, 0112, 0113, 0115, 0118, 0119, 0120, 0121, 0122, 0125, 0126, 0127, 0129, 0130, 0133.
• Recalling Firm/ Manufacturer: Obalon Therapeutics Inc; 5421 Avenida Encinas Ste F; Carlsbad CA 92008-4410
• For Additional Information Contact: 844-362-2566 Ext. 4
• Manufacturer Reason for Recall: During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated.
• FDA Determined Cause: Software design
• Action: To ensure that customers would receive the recall notification bulletin, and to ensure that the bulletin would not be lost in an email inbox, customers were contacted by telephone beginning on 5/23/2019 to notify them that they would be receiving an email containing the notification bulletin. These emails, first sent on 5/23/2019, contained Customer Bulletin no. LIT-7410-0025-01. The bulletin notified customers of the unintended functionality of the touchscreen during power-up, provided instructions to contact Obalon Customer Service immediately it this situation occurs, and contained updated instructions as to how to handle the device issue. Customers were instructed to contact the Obalon Customer Service/Technical Support department to obtain instructions for re-calibrating the touchscreen such that the device will function as designed and the balloon administration may proceed. Customers were requested to immediately report any events that occur with use of the system such that the firm can inform regulatory bodies and customers of any new device information and update labeling materials, where appropriate. Customers were informed that a permanent fix has been identified and once it has been reviewed and approved by FDA, all dispensers will be updated accordingly.
• Quantity in Commerce: 45 units
• Distribution: US Nationwide distribution including the states of VA, NY, GA, TX, TN, OR, FL, LA, CT, and NJ.
• 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.

• PMA Database: PMAs with Product Code = LTI and Original Applicant = ReShape Lifesciences, Inc.