ReShape Integrated Dual Balloon SystemRecalls & reported problems across all models

We found 2 models of ReShape Integrated Dual Balloon System by Reshape Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 99 adverse event reports in the FDA's MAUDE database, received between Feb 18, 2016 and Mar 25, 2020 — classified as 3 deaths, 70 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ReShape Integrated Dual Balloon System problems

ReShape Integrated Dual Balloon System models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ReShape™ Integrated Dual Balloon System RSM101

  Implant, Intragastric For Morbid Obesity
  3 deaths98 reports
• ReShape® Integrated Dual Balloon System RSM110

  Implant, Intragastric For Morbid Obesity
  1 report

Recent ReShape Integrated Dual Balloon System adverse event reports

The 15 most recent reports across all models, 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 ↗