OrcaPod™ SUV-633Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729991144), received between Jul 20, 2020 and Sep 15, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fluid/Blood Leak; Excess Flow or Over-Infusion; Gas/Air Leak

  It was reported to Boston Scientific Corporation that an Orca valve was used during a Colonoscopy procedure performed on an unknown date.During the procedure, the user noted air leaking around the button and observed more bubbles in the colon than usual. The nurse was sprayed with fluid from the scope several times. The procedure was completed using the same device.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776787 ↗
• MalfunctionSep 8, 2026Break; Difficult to Remove; Material Integrity Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658900 ↗
• MalfunctionAug 6, 2026Fluid/Blood Leak; Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164996 ↗
• MalfunctionAug 6, 2026Difficult to Remove; Suction Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161547 ↗
• MalfunctionAug 6, 2026Human-Device Interface Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155751 ↗
• MalfunctionAug 6, 2026Human-Device Interface Problem; Physical Resistance/Sticking

  It was reported to Boston Scientific Corporation that an Orca was used during an Esophagogastroduodenoscopy (EGD) and Colonoscopy procedures on an unknown date, for Screening and Surveillance. During the procedure, the A/W and Suction buttons are difficult to press. Once pressed, they become stuck and do not return to their normal position. The procedure was completed with another of the same device.There were no patient complication as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50155749 ↗
• MalfunctionJul 29, 2026Fluid/Blood Leak

  It was reported to Boston Scientific that OrcaPod 4 was used during a Colonoscopy procedure performed for screening on (b)(6)2026.During the procedure, when the physician pressed the air/water button, water leaked from the device and splashed into the physician's eye.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071780 ↗
• MalfunctionJul 28, 2026Break; Difficult to Remove; Material Integrity Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060486 ↗
• MalfunctionJun 16, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING EGD (ESOPHAGOGASTRODUODENOSCOPY) AND COLONOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE RED SUCTION VALVE REMAINED DEPRESSED AFTER A FEW SECONDS OF USE. THE PROCEDURE WAS COMPLETED USING ANOTHER ORCA DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524897 ↗
• MalfunctionMay 29, 2026Difficult to Remove; Human-Device Interface Problem; Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT ORCA SUCTION BUTTON WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN PROCEDURE DATE. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY PRESSING THE SUCTION BUTTON. WHEN THE STAFF ATTEMPTED TO REMOVE THE BUTTON, THEY ALSO ENCOUNTERED DIFFICULTY DETACHING IT FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; SUCTION BUTTON STICKING. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330747 ↗
• MalfunctionApr 8, 2026Fluid/Blood Leak

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE AIR/WATER VALVE LEAKED PROFUSELY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824415 ↗
• MalfunctionApr 8, 2026Fluid/Blood Leak

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE AIR/WATER VALVE LEAKED PROFUSELY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824410 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Physical Resistance/Sticking; Fluid/Blood Leak; Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA WAS USED DURING AN UNKNOWN PROCEDURE AND AN UNKNOWN DATE. DURING THE PROCEDURE, THE AIR/WATER VALVE LEAKED AND SPRAYED FLUID ONTO THE PHYSICIANS, AND THE SUCTION BUTTON REPEATEDLY BECAME STUCK, REQUIRING MANUAL REMOVAL TO STOP SUCTION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476652 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Physical Resistance/Sticking; Fluid/Blood Leak; Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA WAS USED DURING AN UNKNOWN PROCEDURE AND AN UNKNOWN DATE. DURING THE PROCEDURE, THE AIR/WATER VALVE LEAKED AND SPRAYED FLUID ONTO THE PHYSICIANS, AND THE SUCTION BUTTON REPEATEDLY BECAME STUCK, REQUIRING MANUAL REMOVAL TO STOP SUCTION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476648 ↗
• MalfunctionOct 30, 2025Fluid/Blood Leak; Physical Resistance/Sticking; Fluid/Blood Leak; Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCAPOD 4 WAS USED DURING A GENERAL GASTROINTESTINAL (GI) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE AIR/WATER BUTTON WAS STICKING, AND FLUID LEAKING WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429887 ↗
• MalfunctionOct 1, 2025Fluid/Blood Leak; Excess Flow or Over-Infusion; Infusion or Flow Problem; Fluid/Blood Leak; Excess Flow or Over-Infusion; Infusion or Flow Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA POD WAS USED IN THE COMMON BILE DUCT FOR THE TREATMENT OF COMMON BILE DUCT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, CONTINUOUS OVER-IRRIGATION, SIGNIFICANT WATER LEAKAGE, EXCESSIVE BUBBLING, AND INADEQUATE INSUFFLATION WERE OBSERVED, RESULTING IN POOR VISUALIZATION AND COMPROMISED IMAGING QUALITY. THE PHYSICIAN ATTEMPTED TO ADJUST THE BUTTONS (ON AND OFF), BUT THIS HAD NO POSITIVE EFFECT. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23189725 ↗
• MalfunctionAug 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCAPOD WAS USED DURING A COLONOSCOPY PROCEDURE IN THE COLON FOR THE TREATMENT OF POLYPS PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT THE BLUE AIR/WATER BUTTON WAS LEAKING WATER AFTER BEING INSTALLED ON THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726732 ↗
• MalfunctionJul 28, 2025Fitting Problem; Device-Device Incompatibility

  BOSTON SCIENTIFIC ORCAPOD KIT COMPATIBLE WITH OLYMPUS. (SINGLE-USE AIR/WATER, SUCTION AND BIOPSY VALVE SET WITH WATER JET CONNECTOR). SUCTION VALVES WERE TOO LARGE TO FIT IN THE SUCTION VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22622794 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Suction Problem; Fluid/Blood Leak; Suction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCAPOD WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WATER WAS SPUTTERING FROM THE AIR/WATER VALVE AND ONTO THE PHYSICIAN. HE ALSO REPORTED THAT THE DEVICE'S SUCTION WAS INSUFFICIENT IN MULTIPLE INSTANCES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543394 ↗
• MalfunctionJul 14, 2025Fluid/Blood Leak; Infusion or Flow Problem; Fluid/Blood Leak; Infusion or Flow Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCAPOD WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED IN THE COLON FOR SCREENING ON (B)(6) 2025. DURING THE PROCEDURE, THE AIR/WATER VALVE WAS LEAKING AND COULD NOT GET FULL INSUFFLATION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494268 ↗
• MalfunctionOct 16, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024, FOR THE TREATMENT OF STRICTURE. DURING PREPARATION, THE ORCA AIR WATER BUTTONS BEGAN TO LEAK AS THEY WERE INSERTED INTO THE EXALT MODEL D SINGLE USE DUODENOSCOPE SCOPE. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461272 ↗
• InjuryJan 10, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE BIOPSY CAP BROKE INSIDE THE PATIENT. IT WAS UNKNOWN HOW THE BIOPSY CAP WAS RETRIEVED AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PHOTOS WERE PROVIDED BY THE CUSTOMER AND SHOWED PART OF THE SEAL BIOPSY VALVE BROKEN OFF. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134486 ↗
• MalfunctionSep 14, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDUE, THE BIOPSY CAP CAME OFF THE SCOPE AND THE PHYSICIAN WAS SPRAYED WITH STOOL. REPORTEDLY, THE PHYSICIAN WAS WEARING STANDARD PERSONAL PROTECTIVE EQUIPMENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT AL BIOPSY CAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529086 ↗
• MalfunctionJul 20, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, IT WAS NOTED THAT A PIECE OF THE BIOPSY CAP WAS MISSING. THE PROCEDURE WAS COMPLETED USING THE ORIGNAL SEAL BIOPSY VALVE. REPORTEDLY, THE MISSING PIECE WAS FOUND DURING SCOPE CLEANING AND WAS REMOVED USING A BRUSH. THERE WAS NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295142 ↗