ReShape® Integrated Dual Balloon System RSM110Recalls & reported problems
Reshape Medical, Inc. · IMPLANT, INTRAGASTRIC BALLOON FOR OBESITY · Class 3 · Implant
All models of ReShape Integrated Dual Balloon System (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B001RSM1101), received between Jun 7, 2016 and Jun 7, 2016 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Atrial Flutter1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
BALLOON WAS IMPLANTED ON (B)(6) 2016. PATIENT CONTACTED THE IMPLANTING PHYSICIAN ON (B)(6) 2016 COMPLAINING OF HEAVINESS FROM BALLOONS IN THE CHEST, RAPID HEARTBEAT, AND DIFFICULTY TOLERATING THE DEVICE. PATIENT WAS ADVISED TO GO TO THE CLOSEST ER FOR IV HYDRATION AND EKG. PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016 WITH 2-1 ATRIAL FLUTTER (NO CARDIAC HISTORY). FOLLOWING A CARDIOLOGY EVALUATION, PATIENT'S HEART ISSUE RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2016. PATIENT ELECTED TO HAVE THE BALLOON REMOVED, WHICH WAS COMPLETED ON (B)(6) 2016.
Patient problems: Atrial Flutter
MAUDE report 5705036 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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