NA RLZPT2Recalls & reported problems
Obtech Medical Sàrl · Gastric Band Sutureless Port and Applier · Class 3 · Implant
Data updated Oct 16, 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 20705036004018), received between May 14, 2025 and May 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Mechanical Problem1
- Use of Device Problem1
Patient problems
- Insufficient Information1
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2025Mechanical Problem; Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Use of Device Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING A BAND REMOVAL CONVERSION, WAS ATTEMPTING TO REMOVE THE REALIZE BAND PORT THE SURGEON HAD A LOT OF TROUBLE REMOVING IT. THE PATIENT NOW HAS A SEROMA. THE PORT WAS REMOVED.
Patient problems: Insufficient Information; Unspecified Tissue Injury
MAUDE report 22022011 ↗
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
- OBALON Touch™ 4300-0003Medtimo, Inc · Implant, Intragastric For Morbid Obesity1 recall0 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
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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