OrcaPodRecalls & reported problems across all models

We found 4 models of OrcaPod by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 217 adverse event reports in the FDA's MAUDE database, received between May 23, 2019 and Sep 29, 2026 — classified as 4 injuries, 213 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (91 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 OrcaPod problems

OrcaPod models

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

• OrcaPod™ SUV-629

  Endoscope channel accessory
  112 reports
• OrcaPod™ SUV-628

  endoscopic irrigation/suction system
  79 reports
• OrcaPod™ SUV-633

  Endoscope channel accessory
  24 reports
• OrcaPod™ SUV-632

  endoscopic irrigation/suction system
  2 reports

Recent OrcaPod adverse event reports

The 15 most recent reports across all models, 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 23, 2026Difficult to Remove; Physical Resistance/Sticking

  It was reported to Boston Scientific Corporation that an Orca Suction Valve was used during a procedure on an unknown date. During the procedure, the suction button became stuck in the depressed position. Force was required to remove the button. The procedure was completed with a different model device. No patient complications or adverse effects were reported in relation to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871266 ↗
• MalfunctionSep 21, 2026Break; Difficult to Remove; Material Integrity Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847256 ↗
• MalfunctionSep 21, 2026Break; Difficult to Remove; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847225 ↗
• 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 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 11, 2026Difficult to Remove; Physical Resistance/Sticking

  It was reported to Boston Scientific Corporation that an Orca Valve was used during an Esophagogastroduodenoscopy (EGD) procedure for the treatment of tissue resection performed on (b)(6) 2026.During the procedure, the physician observed that the button became stuck within the scope. Upon completion of the procedure, the button was difficult to remove. 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 50735035 ↗
• MalfunctionSep 11, 2026Difficult to Remove; Physical Resistance/Sticking

  It was reported to Boston Scientific Corporation that an Orca Valve was used during an Esophagogastroduodenoscopy (EGD) procedure for the treatment of tissue resection performed on (b)(6) 2026. During the procedure, the physician observed that the button became stuck within the scope. Upon completion of the procedure, the button was difficult to remove. The procedure was completed with another of the same device. There was no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734691 ↗
• MalfunctionSep 11, 2026Break; Difficult to Remove; Material Integrity Problem; Physical Resistance/Sticking

  It was reported to Boston Scientific Corporation that an Orca Valve during an Esophagogastroduodenoscopy (EGD) procedure for the treatment of tissue resection performed on (b)(6) 2026. During the procedure, the physician observed that the button became stuck within the scope. The procedure was completed with another of the same device. Upon completion of the procedure, the button could not be removed and ultimately broke off inside the scope. There was no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734550 ↗
• 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 8, 2026Break; Difficult to Remove; Material Integrity Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658900 ↗
• 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 ↗

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