OrcaPod™ SUV-632Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729991137), received between Aug 11, 2025 and Jul 15, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Fluid/Blood Leak; Excess Flow or Over-Infusion; Suction Problem; Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25830627 ↗
• MalfunctionAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCAPOD WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED FOR SCREENING ON (B)(6) 2025. DURING THE PROCEDURE, THE AIR/WATER BUTTON BEGAN LEAKING WATER AFTER IT WAS ATTACHED TO THE SCOPE. THEY TRIED TAKING IT OFF AND PUTTING IT BACK ON, HOWEVER, THE SAME PROBLEM OCCURRED. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772681 ↗