OrcaPod™ SUV-628Recalls & reported problems
Boston Scientific Corporation · Single Use Air/Water, Suction and Biopsy Valves Set · Class 2
Quick summary
This Boston Scientific OrcaPod suction and biopsy valve set is used for irrigation and suction during endoscopy. The 71 reports mostly describe the suction button leaking fluid, sticking when pressed, suction cutting in and out, and parts coming loose, with no deaths and no injuries. No recalls name this device. Reports rose from 2 in the earlier 12 months to 41 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 79
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 08714729981558), received between Jun 18, 2019 and Sep 23, 2026 — classified as 79 malfunctions.
The most frequently reported specific device problem is “Suction Problem” (34 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.
Reports received per month
Most reported problems
Device problems
- Suction Problem34
- Fluid/Blood Leak33
- Leak/Splash30
- Physical Resistance/Sticking30
- Infusion or Flow Problem21
- Detachment of Device or Device Component19
- Difficult to Remove13
- Break5
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- No Consequences Or Impact To Patient13
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
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 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 ↗MalfunctionAug 18, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310224 ↗MalfunctionAug 18, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310219 ↗MalfunctionAug 18, 2026Fluid/Blood Leak; Suction Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50291261 ↗MalfunctionAug 18, 2026Fluid/Blood Leak; Suction Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50291254 ↗MalfunctionAug 18, 2026Fluid/Blood Leak; Suction Problem; Physical Resistance/Sticking
It was reported to Boston Scientific Corporation that OrcaPod 3 was used in the colon during a Colonoscopy procedure performed on an unknown procedure date.During the procedure, the red suction button exhibited leakage, sticking when depressed, and intermittent suction problem. When suction stopped functioning, the physician would remove the suction button and occlude the suction port with a finger to restore suction. Although this temporarily resolved the issue, the problem repeatedly recurred throughout the procedure. The procedure was completed with this 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 50291253 ↗MalfunctionAug 14, 2026Fluid/Blood Leak; Suction Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245629 ↗MalfunctionAug 14, 2026Fluid/Blood Leak; Suction Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245615 ↗MalfunctionAug 14, 2026Fluid/Blood Leak; Suction Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245614 ↗MalfunctionAug 14, 2026Fluid/Blood Leak; Suction Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245611 ↗MalfunctionAug 14, 2026Fluid/Blood Leak; Suction Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245610 ↗MalfunctionAug 13, 2026Fluid/Blood Leak; Suction Problem; Physical Resistance/Sticking
It was reported to Boston Scientific Corporation that OrcaPod 3 was used in the colon during a Colonoscopy procedure performed on an unknown procedure date.During the procedure, the red suction button exhibited leakage, sticking when depressed, and intermittent suction problem. When suction stopped functioning, the physician would remove the suction button and occlude the suction port with a finger to restore suction. Although this temporarily resolved the issue, the problem repeatedly recurred throughout the procedure. 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 50243509 ↗MalfunctionJul 30, 2026Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50091171 ↗MalfunctionJul 28, 2026Break; Suction Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059702 ↗MalfunctionJul 21, 2026Fluid/Blood Leak; Suction Problem; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25895625 ↗MalfunctionJul 20, 2026Fluid/Blood Leak; Suction Problem; Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25874605 ↗MalfunctionJul 20, 2026Fluid/Blood Leak; Suction Problem; Infusion or Flow Problem
It was reported to Boston Scientific Corporation that Orca valve was used during an Esophagogastroduodenoscopy (EGD) procedure performed on an unknown date, for biopsy. During the procedure, the physician experienced an air/water button leak, a flow issue, and a suction problem. Despite these issues, the procedure was completed using the same device. The physician reported that the procedure was delayed as a result of these issues. There were no patient complications reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25874073 ↗MalfunctionJul 20, 2026Fluid/Blood Leak; Suction Problem; Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25874072 ↗MalfunctionJul 20, 2026Fluid/Blood Leak; Suction Problem; Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25874066 ↗MalfunctionJul 20, 2026Fluid/Blood Leak; Suction Problem; Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25874055 ↗
Other endoscopic irrigation/suction system devices
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- ERBEFLO CleverCap® 20325-201Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 reports
- andorate® A/W Channel Cleaning Adapter + 4-piece Valve Kit GAR3846GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- Suction Valve EN10232GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- ERBEFLO CleverCap® 20325-203Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 reports
- BullDog® 1203-71Diversatek Healthcare, Inc. · Endoscopic Irrigation/Suction System1 recall0 reports
- ERBEFLO® 2 20325-222Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 reports
- 4-piece valve kit(Suction, Air/Water, Biopsy Valves & Auxiliary Water Connector) EN10229.1GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.