PlainRecalls
FDA Devices Moderate Class II Completed

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.

Reported: May 6, 2020 Initiated: May 23, 2019 #Z-1805-2020

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.

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.

Details

Recalling Firm
Obalon Therapeutics Inc
Units Affected
45 units
Distribution
US Nationwide distribution including the states of VA, NY, GA, TX, TN, OR, FL, LA, CT, and NJ.
Location
Carlsbad, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Obalon Therapeutics Inc. Units affected: 45 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1805-2020.

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