LAP-BAND Tubing Kit A-20401Recalls & reported problems
Apollo Endosurgery, Inc. · LAP-BAND TUBING KIT (APOLLO) · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10811955020060), received between Aug 15, 2016 and Aug 15, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Defective Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2016Defective Component; Defective Component
REPORTED AS: THE PHYSICIAN WAS PERFORMING A LAP-BAND SYSTEM TUBING REVISION SURGERY, AND UPON OPENING THE UNIT, NOTED "LAP-BAND SYSTEM TUBING KIT REFERENCE NUMBER (B)(4) WAS DEFECTIVE. PART NUMBER SS CONNECTOR THE LUMEN WAS NOT PATENT. SCRUB TECH WAS IRRIGATING THE LUMEN AND WAS NOT ABLE TO GET THE TUBING TO WORK. THE TUBING WAS MOVED TO A TABLE AND A METAL CHARD CAME OUT WHILE IRRIGATING. DEFECTIVE TUBING (CONNECTOR) CAUSED THE PATIENT TO HAVE ANOTHER SURGERY TO CORRECT THE TUBING." THE PATIENT WAS SCHEDULED AT A LATER TIME TO HAVE THE LAP-BAND TUBING REPLACED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5875720 ↗
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- OBALON® Balloon Kit HPMC 7600-0001Medtimo, Inc · Implant, Intragastric For Morbid Obesity20 reports
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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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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