Reported May 6, 2020 · Completed
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The…
Obalon Therapeutics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Obalon Therapeutics Inc · 5421 Avenida Encinas Ste F · Carlsbad, CA · 92008-4410
Is this the product you have?
- Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 -
- Product UsageThe 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
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 0085981000610400859810006104 2 Model No.: Model 4300 Touch Dispenser 3 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. - Amount recalled
- 45 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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