OBALON Touch™ 4300-0003Recalls & reported problems
Medtimo, Inc · OBALON Touch™ Dispenser - component to inflate the OBALON® Balloon · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- May 23, 2019Completed
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.
Z-1805-2020 · Root cause: Software design · Recall details · FDA record ↗
Other Implant, Intragastric For Morbid Obesity devices
- ORBERA Intragastric Balloon System B-4800Apollo Endosurgery, Inc. · Implant, Intragastric For Morbid Obesity6 deaths327 reports
- ReShape™ Integrated Dual Balloon System RSM101Reshape Medical, Inc. · Implant, Intragastric For Morbid Obesity3 deaths98 reports
- LAP-BAND AP Adjustable Gastric Banding System B-2240Apollo Endosurgery, Inc. · Implant, Intragastric For Morbid Obesity82 reports
- LAP-BAND AP Adjustable Gastric Banding System B-2245Apollo Endosurgery, Inc. · Implant, Intragastric For Morbid Obesity27 reports
- The LAP-BAND Adjustable Gastric Banding System B-2220Apollo Endosurgery, Inc. · Implant, Intragastric For Morbid Obesity25 reports
- OBALON® Balloon Kit HPMC 7600-0001Medtimo, Inc · Implant, Intragastric For Morbid Obesity20 reports
- LAP-BAND AP Adjustable Gastric Banding System B-2260Apollo Endosurgery, Inc. · Implant, Intragastric For Morbid Obesity18 reports
- OBALON® Balloon Kit 7500-0001Medtimo, Inc · Implant, Intragastric For Morbid Obesity14 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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