OrcaPod™ SUV-629Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 08714729981572), received between May 23, 2019 and Sep 29, 2026 — classified as 3 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (44 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 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935996 ↗
• MalfunctionSep 14, 2026Physical Resistance/Sticking

  It was reported to Boston Scientific Corporation that an OrcaPod 4 was used in the colon during various endoscopy procedures performed on (b)(6) 2026. During the procedure, the physician reported that the suction button stuck in the depressed position. There were no patient complications reported as a result of this event and the patient's condition is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758400 ↗
• MalfunctionSep 14, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757628 ↗
• MalfunctionSep 14, 2026Nonstandard Device; Physical Resistance/Sticking

  It was reported to Boston Scientific Corporation that an OrcaPod 4 was used in the colon during various endoscopy procedures performed on (b)(6) 2026. During the procedure, the physician reported that the suction button stuck in the depressed position. It was also reported that the button detached and popped off the scope.There were no patient complications reported as a result of this event and the patient's condition is stable.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 50757275 ↗
• MalfunctionSep 10, 2026Break; Difficult to Remove; Material Integrity Problem; Physical Resistance/Sticking

  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 red suction button became stuck in the depressed position and did not return to its standard position. Attempts to remove and replace the suction button were unsuccessful, and a hemostat was required to extract the device. The procedure was completed using another Orca suction button of the same type.Following the procedure, the endoscope was sent for repair. Upon return of the scope, facility personnel performed a functional test and observed that the suction button could not be properly seated in the suction port. Further inspection of the suction well revealed a broken fragment of the suction button shaft lodged within the port. No visible damage had been identified at the time of the original procedure, and the shaft fracture was not recognized until the subsequent inspection. The issue was isolated to the red suction button; the blue air/water button was not involved.No patient complication was reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714637 ↗
• MalfunctionSep 7, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658830 ↗
• MalfunctionSep 1, 2026Fluid/Blood Leak

  It was reported to Boston Scientific Corporation that an OrcaPod 4 was used during procedure performed on an unknown procedure date.During the procedure, the nurse reported that the air/water button leaked continuously throughout the case; requiring her to place a towel beneath the physician to absorb the excess water. The procedure was completed with this device.There were no patient complications reported as a result of this event and the patient's condition is stable.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 50534788 ↗
• MalfunctionSep 1, 2026Break; Difficult to Remove; Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50534786 ↗
• MalfunctionAug 24, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419128 ↗
• MalfunctionAug 19, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326193 ↗
• MalfunctionAug 19, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326188 ↗
• MalfunctionAug 18, 2026Fluid/Blood Leak

  It was reported to Boston Scientific Corporation that an OrcaPod 4 was used in the gastrointestinal tract during a Gastroscopy procedure for the treatment of Polyps performed on (b)(6) 2026. During the procedure, the nurse observed that the water was escaping from the Air / Watter button. The procedure was completed using another of the same device.There was no patient complications reported as a result of this event and the patient's condition is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50291898 ↗
• MalfunctionAug 18, 2026Fluid/Blood Leak

  It was reported to Boston Scientific Corporation that an OrcaPod 4 was used during a Colonoscopy procedure on (b)(6) 2026. During the procedure, the nurse observed that the water was escaping from the Air / Watter button. The procedure was completed using this device.There were no patient complications reported as a result of this event and the patient's condition is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50291897 ↗
• MalfunctionAug 18, 2026Suction Problem; Physical Resistance/Sticking

  It was reported to Boston Scientific that an Orca valve was used for colon during a Colonoscopy procedure performed on July 21, 2026, for colonoscopy screening.During procedure, the suction button sticking. The procedure was completed using the same device.There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50291249 ↗
• MalfunctionAug 5, 2026Unsealed Device Packaging; Device Contaminated During Manufacture or Shipping; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50136764 ↗
• MalfunctionJul 27, 2026Physical Resistance/Sticking

  It was reported to Boston Scientific Corporation that an OrcaPod 4 was used in the colon during a Colonoscopy procedure for the treatment of Polyps performed on (b)(6)2026. During the procedure, the suction button was sticking and was not returning to its original position after being pressed. The procedure was completed using this device.There were no patient complications reported as a result of this event and the patient's condition is stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50020387 ↗
• MalfunctionJul 27, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50020075 ↗
• MalfunctionJul 26, 2026Fluid/Blood Leak; Use of Device Problem; Physical Resistance/Sticking

  Patient problems: Exposure to Body Fluids

  MAUDE report 50000031 ↗
• MalfunctionJul 20, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25880612 ↗
• MalfunctionJul 10, 2026Suction Problem; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. IT WAS REPORTED THAT THE ORCA BUTTON IS NOT INSUFFLATING PROPERLY. THE SUCTION BUTTON BECOMES STUCK IN THE DEPRESSED POSITION, RESULTING IN INADEQUATE SUCTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788511 ↗
• MalfunctionJul 10, 2026Break; Suction Problem; Infusion or Flow Problem; Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING COLONOSCOPY AND ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THEY REPORTED FREQUENT ISSUES WITH THE NEW BUTTONS, INCLUDING WEAK AND NO INSUFFLATION, INADEQUATE SUCTION, THE SUCTION BUTTON BECOMING STUCK IN THE DEPRESSED POSITION, AND ONE INSTANCE IN WHICH THE BUTTON STEM BROKE OFF INTO THE SCOPE VALVE DURING BEDSIDE CLEANING. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25788503 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak; Infusion or Flow Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE AIR/WATER BUTTON WAS LEAKING WATER AND NOT PROVIDING ENOUGH INSUFFLATION. THE PROCEDURE WAS COMPLETED USING 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 25333518 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak; Infusion or Flow Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING A PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE AIR/WATER BUTTON WAS LEAKING WATER AND NOT PROVIDING ENOUGH INSUFFLATION. THE PROCEDURE WAS COMPLETED USING 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 25333515 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak; Infusion or Flow Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE AIR/WATER BUTTON WAS LEAKING WATER AND NOT PROVIDING ENOUGH INSUFFLATION. THE PROCEDURE WAS COMPLETED USING 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 25333514 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak; Infusion or Flow Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING PROCEDURE PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE AIR/WATER BUTTON WAS LEAKING WATER AND NOT PROVIDING ENOUGH INSUFFLATION. THE PROCEDURE WAS COMPLETED USING 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 25333498 ↗