ReShape™ Integrated Dual Balloon System RSM101Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI B001RSM1011), received between Feb 18, 2016 and Mar 25, 2020 — classified as 3 deaths, 69 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 reports).

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

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APOLLO ENDOSURGERY RECEIVED MEDWATCH FORM (MW5092500), PER FORM, PATIENT WAS RUSHED TO HOSPITAL TO HAVE THE DEVICE REMOVED DUE TO PERFORATED ABDOMINAL VISCUS CAUSING PAIN AND SEPSIS.

  Patient problems: Pain; Patient Problem/Medical Problem; Sepsis

  MAUDE report 9881063 ↗
• MalfunctionDec 10, 2019Deflation Problem; Deflation Problem

  RECEIVED FROM RESHAPE ON 12NOV2019. THEY HAD RECEIVED IT VIA MEDWATCH MW5090562. FROM MEDWATCH: RESHAPE DUO BALLOONS FOR WEIGHT LOSS, THE BALLOONS BURST INSIDE MY STOMACH. THE BLUE DYE THAT WAS INSERTED DID NOT SHOW SIGNS OF COLOR IN MY URINE. HAD TERRIBLE STOMACH PAINS FOR MONTHS AND WAS TOLD IT WAS NORMAL AND I EXPERIENCED BAD ODOR IN URINE AND A VERY DARK YELLOW COLOR. THIS BALLOON SAT IN MY STOMACH FOR 6 MONTHS AND I NOTICE A PROBLEM AROUND 3 MONTHS WHERE MY APPETITE INCREASED BACK AND I REPORTED THIS TO THE CLINIC AND WAS TOLD TO EAT MORE PROTEIN FIRST. I PAID $7500 AND DIDN'T GET ANY RESULTS AND NOT EVEN A REPLACEMENT. I WAS TOLD BY THE DR THAT RESHAPE DUO THE COMPANY WAS DISCONTINUING THIS BALLOON, AND HE ONLY HAD A FEW LEFT BECAUSE IT WAS GOING OFF MARKET. WENT ON (B)(6) 2019 TO GET BALLOONS REMOVED AND THEY INFORMED ME THAT THE BALLOONS HAD BURST OPEN AND PHOTOS WAS TAKEN AND IT WAS REPORTED IN MY MEDICAL RECORDS. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Pain

  MAUDE report 9447407 ↗
• MalfunctionMay 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT HAD THE RESHAPE DUAL BALLOON SUCCESSFULLY IMPLANTED APPROXIMATELY TWO (2) MONTHS AGO. IN THE LAST FEW WEEKS, THE PATIENT NOTED DISCOLORED URINE AND DECREASE IN SATIETY. THE PATIENT IS SCHEDULED FOR AN EGD TO DETERMINE IF THE BALLOON(S) ARE LEAKING.

  Patient problems: Failure of Implant

  MAUDE report 8636698 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH THE RESHAPE DUAL BALLOON SYSTEM HAD COMPLAINTS OF INTENSE PAIN RADIATING TO THEIR BACK. THE PATIENT'S LAB RESULTS NOTED A LIPASE OF 26,000. THE PATIENT WAS FLOWN EMERGENTLY TO A HOSPITAL FOR REMOVAL OF THE DEVICE DUE TO PANCREATITIS. THE PATIENT WAS DISCHARGED AFTER THE NORMALIZATION OF THEIR LIPASE AND RESOLUTION OF THE ABDOMINAL PAIN.

  Patient problems: Inflammation; Pain

  MAUDE report 8601765 ↗
• MalfunctionFeb 26, 2019Leak/Splash; Leak/Splash

  THE BALLOON WAS INSERTED ON (B)(6) 2018. DURING THE SIX MONTH REMOVAL ON (B)(6) 2019, THE PHYSICIAN NOTED THE DISTAL BALLOON WAS DEFLATED. THE PATIENT WAS COMPLIANT WITH TAKING THEIR PPI'S.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370391 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BALLOON WAS INSERTED ON (B)(6) 2018. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) WITH SEVERE VOMITING, ABDOMINAL PAIN AND SWEATING. THE BALLOON WAS REMOVED ON (B)(6) 2018 AND THE PATIENT WAS TREATED FOR DEHYDRATION. THE BALLOON WAS REMOVED WITH NO ISSUES AND THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Abdominal Pain; Vomiting

  MAUDE report 8310316 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BALLOON WAS INSERTED ON (B)(6) 2018. THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO ABDOMINAL PAIN AND WAS DIAGNOSED WITH PANCREATITIS. THE BALLOON WAS REMOVED ON (B)(6) 2018. THE PATIENT WAS COMPLIANT WITH TAKING THEIR PPI'S.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8189916 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BALLOON WAS INSERTED ON (B)(6) 2018. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018 WITH A GASTRIC PERFORATION. THE PHYSICIAN CHECKED THAT BOTH BALLOONS WERE INTACT, REMOVED THE BALLOONS AND REPAIRED THE GASTRIC PERFORATION ON THE SAME DAY. THE PATIENT WAS GIVEN ANTIBIOTICS FOR SEPSIS. EACH BALLOON WAS FILLED TO 450CCS AND THE PATIENT WAS TALLER THAN (B)(6). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018.

  Patient problems: Perforation

  MAUDE report 8185267 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BALLOONS WERE INSERTED ON (B)(6) 2018. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM ON (B)(6) 2018 COMPLAINING OF NAUSEA, VOMITING, AND DEHYDRATION; THE PATIENT WAS DISCHARGED ON (B)(6) 2018. TWO DAYS LATER, THE PATIENT WAS RE-ADMITTED TO THE EMERGENCY ROOM AND DISCHARGED ON (B)(6) 2018. THE BALLOON WAS REMOVED ON (B)(6) 2018.

  Patient problems: Nausea; Vomiting

  MAUDE report 8185183 ↗
• MalfunctionNov 28, 2018Leak/Splash; Migration; Leak/Splash; Migration

  ON (B)(6) 2018, THE BALLOONS WERE FILLED TO 450CC AND INSERTED INTO THE PATIENT. DURING THE REMOVAL SURGERY ON (B)(6) 2018, THE BALLOON WAS NOT PRESENT IN THE STOMACH. ON (B)(6) 2018, THE PATIENT INFORMED THE PHYSICIAN'S OFFICE THAT THE BALLOON HAD PASSED WHILE THE PATIENT WAS AT WORK. THE PATIENT WAS COMPLIANT WITH TAKING PPI'S AND DID NOT NOTE ANY BLUE/GREEN URINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8110986 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE BALLOON WAS INSERTED WITH NO COMPLICATIONS. THE PHYSICIAN PERFORMED AN EGD POST-INSERTION TO CHECK BALLOON PLACEMENT, NOTED BLEEDING AND DISMISSED THE PATIENT. THE NEXT DAY, (B)(6) 2018, THE PATIENT WAS ADMITTED TO THE HOSPITAL REPORTING SEVERE ABDOMINAL PAIN AND DIFFICULTY BREATHING. THE PATIENT CONTINUED TO FEEL THESE SYMPTOMS THE FOLLOWING DAY, THE PHYSICIAN DECIDED TO REMOVE THE BALLOONS. THE PHYSICIAN REMOVED THE BALLOONS WITH NO COMPLICATIONS; HOWEVER, DURING THE POST-REMOVAL EGD, A PRESSURE ULCER WAS FOUND AT THE GI JUNCTION. THE PATIENT WAS DISCHARGED ON (B)(6) 2018. THE PATIENT WAS NOT COMPLIANT WITH TAKING THEIR PPI'S.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 8051408 ↗
• MalfunctionOct 10, 2018Leak/Splash; Leak/Splash

  THE BALLOON WAS INSERTED ON (B)(6) 2018. DURING THE SCHEDULED ROUTINE REMOVAL ON (B)(6) 2018, THE PHYSICIAN FOUND THE DISTAL BALLOON DEFLATED UPON INSERTION OF THE SCOPE. THE PATIENT REPORTED NO BLUE/GREEN URINE OR ANY OTHER TYPE OF SYMPTOMS PRIOR TO THE REMOVAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7951485 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BALLOON WAS INSERTED ON (B)(6) 2018. THE PATIENT CHECKED INTO THE ICU AT (B)(6) CENTER WITH AN ULCER ON THE FUNDUS AND NEEDED ADDITIONAL BLOOD. THE PATIENT STARTED ON BLOOD THINNERS AS SOME POINT AFTER THE BALLOON WAS INSERTED. THE BALLOON WAS REMOVED ON (B)(6) 2018. THE PATIENT IS DOING FINE POST REMOVAL.

  Patient problems: Ulcer

  MAUDE report 7782624 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BALLOON WAS INSERTED ON (B)(6) 2018. THIRTY-SIX HOURS LATER, THE PATIENT WAS HOSPITALIZED WITH SEVERE NAUSEA, VOMITING AND ABDOMINAL PAIN RIGHT AFTER THE PLACEMENT OF THE BALLOON. DURING THE REMOVAL OF THE BALLOON, THE PHYSICIAN NOTED A LOT OF FLUID IN THE STOMACH AND THE FLUID WAS NOT EMPTYING WHICH WAS PROBABLY CAUSING THE SEVERE SYMPTOMS. ONCE THE BALLOON WAS REMOVED, THE SYMPTOMS RESOLVED IMMEDIATELY.

  Patient problems: Abdominal Pain; Nausea; Vomiting

  MAUDE report 7781192 ↗
• MalfunctionAug 7, 2018Leak/Splash; Leak/Splash

  THE BALLOON WAS INSERTED ON (B)(6) 2018. ON (B)(6) 2018, AT THE SIX-MONTH ROUTINE REMOVAL, THE DISTAL BALLOON WAS FOUND DEFLATED. THE PATIENT DID NOT REPORT ANY DISCOLORED URINE AND WAS COMPLIANT WITH TAKING THE PPI'S.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7758740 ↗
• InjuryJul 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BALLOON WS INSERTED ON (B)(6) 2018. POST INSERTION, THE PATIENT WAS ADMITTED TWICE TO THE HOSPITAL, THE FIRST TIME FOR DEHYDRATION AND THE SECOND TIME FOR ASPIRATION PNEUMONIA. ON (B)(6) 2018, THE PATIENT WAS ADVISED BY THEIR PHYSICIAN TO RETURN TO THE EMERGENCY ROOM FOR ANOTHER DEHYDRATION TREATMENT. THE PATIENT WAS ADVISED THAT THE BALLOON MAY HAVE CAUSED THE ASPIRATION PNEUMONIA AND WAS PRESCRIBED REFLUX MEDICATION. THE PATIENT CONTINUED TO VOMIT ON A REGULAR BASIS AND IS SCHEDULED FOR A FOLLOW UP VISIT WITH THEIR PHYSICIAN PENDING THE DEHYDRATION TREATMENT WHICH WOULD LIKELY LEAD TO A REMOVAL. THE PATIENT EXPRESSED THEY WOULD LIKE TO LEAVE THE BALLOON IN AND POSSIBLY FILLING THE BALLOON LESS.

  Patient problems: Aspiration/Inhalation; Dehydration; Vomiting

  MAUDE report 7731711 ↗
• InjuryJul 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BALLOONS WERE INSERTED ON (B)(6) 2017. IN (B)(6) 2018, THE PATIENT REPORTED BURNING SENSATION AND DISCOMFORT IN THE STOMACH AREA THAT PROGRESSIVELY GOT WORSE. THE PATIENT VISITED THE PHYSICIAN'S OFFICE AND WAS PRESCRIBED ACID REFLUX MEDICATION AND TWO ADDITIONAL MEDICATIONS TO HELP WITH DISCOMFORT. THE PATIENT REPORTED HAVING AN MRI AND HIGH LIVER ENZYMES. THE BALLOONS WERE REMOVED ON (B)(6) 2018. THE PATIENT STATED THE PAIN AND DISCOMFORT STOPPED ONCE THE BALLOONS WERE REMOVED. DURING THE WEEK OF (B)(6) 2018, THE PATIENT WAS SEEN FOR AN EGD AND AN ABLATION OF THE ESOPHAGUS, WHICH WERE UNRELATED TO THE BALLOON SYMPTOMS AND PROCEDURE.

  Patient problems: Abdominal Pain; Burning Sensation

  MAUDE report 7716582 ↗
• MalfunctionJul 19, 2018Migration; Migration

  THE BALLOON WAS INSERTED ON (B)(6) 2017. THE DEVICE WAS SCHEDULED FOR REMOVAL ON (B)(6) 2018, 15 - MONTHS POST INSERTION. WHEN THE EGD WAS PERFORMED, THERE WAS NO BALLOON FOUND IN THE STOMACH. AFTER IMAGING, THERE WAS NO RADIOPAQUE MARKER SEEN WITHIN THE GI TRACT. THE PATIENT HAD NO BLUE/GREEN URINE AND APPEARS TO BE FINE POST-OP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704587 ↗
• MalfunctionJul 12, 2018Material Rupture; Material Rupture

  GASTRIC BALLOON RUPTURED AND WAS REMOVED ON (B)(6) 2018. UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT STATUS OR DETAILS RELATED TO THE RUPTURED BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7683692 ↗
• MalfunctionJul 12, 2018Leak/Splash; Leak/Splash

  THE BALLOON WAS INSERTED ON (B)(6) 2017. THE PATIENT REPORTED EXPERIENCING BLUE/GREEN URINE BUT DID NOT CONTACT THEIR PHYSICIAN OR PURSUE AN X-RAY TO DETERMINE THE CAUSE. THE PATIENT WENT THE FULL 6 MONTHS WITH THE BALLOON AND WAS REMOVED ON (B)(6) 2018. DURING THE REMOVAL, THE BALLOON WAS FOUND TO BE DEFLATED. THE PATIENT WAS COMPLIANT WITH TAKING THEIR PPI AND WAS NEVER ADMITTED TO THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7683685 ↗
• InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD VISITED THE EMERGENCY ROOM TWICE WITH DISCOMFORT AND NAUSEA AND WAS ADMITTED TO THE HOSPITAL ONCE WITH THE SAME SYMPTOMS. RESHAPE LIFESCIENCES CUSTOMER SERVICE REACHED OUT TO THE PRACTICE AND SPOKE WITH THE PHYSICIAN DIRECTLY AND HE STATED THE PATIENT HAD AN APPOINTMENT THIS WEEK COMPLAINING OF NAUSEA, VOMITING, AND MENTIONED THE FOOD TENDS TO SIT IN THE ESOPHAGUS AND CAUSES DISCOMFORT. DURING THE APPOINTMENT, THE PATIENT STATED THEY WERE TAKING IBUPROFREN; HOWEVER, THE PHYSICIAN ASKED THE PATIENT NOT TO TAKE IBUPROFREN ANYMORE AND PRESCRIBED ANOTHER MEDICATION. THE PHYSICIAN ALSO NOTED THE PATIENT HAS DEPRESSION AND THOUGHT THIS WAS EXASPERATED DUE TO THE CONDITION. THE PATIENT REPORTEDLY HAD THE BALLOONS REMOVED ON (B)(6) 2018.

  Patient problems: Nausea; Vomiting

  MAUDE report 7577936 ↗
• MalfunctionJun 7, 2018Detachment Of Device Component; Detachment Of Device Component

  THE BALLOONS WERE INSERTED ON (B)(6) 2017. ON (B)(6) 2018, DURING THE 6-MONTH REMOVAL, THE PROXIMAL CAP BROKE OFF. THE SURGICAL TEAM TRIED SNARING THE PROXIMAL CAP AND THEN THE BUTTON ON TOP SNAPPED OFF TOO. THE TEAM TRIED GRABBING THE SKIN OF THE BALLOON WITH TWO RAT TOOTH GRASPERS VIA A DUAL CHANNEL SCOPE BUT THIS WAS VERY CHALLENGING AS THE SILICONE KEPT TEARING. THE PHYSICIAN WAS ABLE TO SNARE THE BALLOON AT A LOWER POINT OF THE PROXIMAL BALLOON. THE BALLOON AND ALL COMPONENTS WERE REMOVED SAFELY AND THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7577934 ↗
• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BALLOONS WERE INSERTED ON (B)(6) 2018. THE NEXT DAY, THE PATIENT REPORTED A TEMPERATURE OF 101, CHEST PAIN AND VOMITING. A CHEST AND ABDOMINAL CT SCANS WITH ORAL CONTRAST WERE PERFORMED. THE CT CHEST WAS NORMAL, THE CT ABDOMINAL SHOWED THE BALLOON IN PLACE, DISTENDED GASTRIC FUNDUS, AND RETAINED GASTRIC CONTENTS SURROUNDING THE BALLOON. THE DEVICE WAS REMOVED ON (B)(6) 2018. ADDITIONAL INFORMATION RECEIVED ON APRIL 24, 2018 CONFIRMED THERE WAS A GASTRIC OUTLET OBSTRUCTION. THE PATIENT WAS REPORTED TO BE DOING FINE FOLLOWING THE DEVICE REMOVAL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 7557233 ↗
• MalfunctionMay 24, 2018Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  THE PATIENT HAD THE BALLOONS INSERTED ON (B)(6) 2017. AROUND (B)(6) 2018, THE PATIENT PASSED BOTH BALLOONS. THE PATIENT REPORTED NO SYMPTOMS OF PAIN OR DISCOMFORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7542215 ↗
• InjuryMay 24, 2018Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  THE PATIENT HAD THE BALLOONS INSERTED ON (B)(6) 2018. DURING THE INSERTION, THE PHYSICIAN HAD DIFFICULTY PASSING THE BALLOON CATHETER OVER THE WIRE DUE TO DIFFICULT PATIENT ANATOMY. THE PATIENT HAD EXCESSIVE EPIGLOTTIC AND HYPOPHARYNEAL TISSUE WHICH WAS NOT ALLOWING THE PASSING OF THE CATHETER. THIS CAUSED TRAUMA AND SWELLING TO THE HYPOPHARYNX. THE PHYSICIAN ABORTED THE PROCEDURE. RESHAPE MEDICAL HAS REACHED OUT TO THE CUSTOMER REGARDING THE PATIENT STATUS POST OPERATIVELY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 7541073 ↗