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Obalon Balloon System with Model 4300 Touch Dispenser… recallZ-1805-2020 · Obalon Therapeutics Inc · initiated May 23, 2019

Completed

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Obalon Therapeutics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-1805-2020
Status
Completed
Initiated by the company
May 23, 2019
Recalling firm
Obalon Therapeutics Inc
Quantity
45 units
Product code
LTI
FDA submissions
P160001S020, P160001S007
Distribution
US Nationwide distribution including the states of VA, NY, GA, TX, TN, OR, FL, LA, CT, and NJ.

Product description

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 (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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