Orca™ SUV-617Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00840253111012), received between Sep 11, 2024 and Jul 30, 2026 — classified as 1 injury, 63 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (57 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 12, 2026Open, Classified

   Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.

   Z-2413-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Fluid/Blood Leak; Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091379 ↗
• MalfunctionJul 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091058 ↗
• MalfunctionMay 28, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA BUTTON WAS USED DURING PROCEDURE PERFORMED ON (B)(6) 2026. THE SUCTION BUTTON COULD NO LONGER BE PRESSED. 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 25319714 ↗
• MalfunctionMay 27, 2026Suction Problem; Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT ORCA AIR WATER AND SUCTION VALVES WERE USED IN A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. THE SUCTION BUTTON BECAME STUCK, AND NOT GIVING CONSISTENT SUCTION. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303081 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TEN ORCA VALVES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR THE TREATMENT OF GERD ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE RED SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION AFTER INSERTION. THE PHYSICIAN ATTEMPTED TO REMOVE AND REINSERT THE BUTTON SEVERAL TIMES, BUT THE ISSUE PERSISTED. A NEW PACK OF BUTTONS OF THE SAME TYPE WAS THEN OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301770 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION DURING THE PROCEDURE. 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 25301709 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TEN ORCA VALVES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR THE TREATMENT OF GERD ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE RED SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION AFTER INSERTION. THE PHYSICIAN ATTEMPTED TO REMOVE AND REINSERT THE BUTTON SEVERAL TIMES, BUT THE ISSUE PERSISTED. A NEW PACK OF BUTTONS OF THE SAME TYPE WAS THEN OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301392 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TEN ORCA VALVES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR THE TREATMENT OF GERD ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE RED SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION AFTER INSERTION. THE PHYSICIAN ATTEMPTED TO REMOVE AND REINSERT THE BUTTON SEVERAL TIMES, BUT THE ISSUE PERSISTED. A NEW PACK OF BUTTONS OF THE SAME TYPE WAS THEN OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301390 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED FOR COLON DURING COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026 FOR THE TREATMENT OF POLYPS. DURING THE PROCEDURE THE SUCTION BUTTON STUCK. 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 25301389 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TEN ORCA VALVES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR THE TREATMENT OF GERD ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE RED SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION AFTER INSERTION. THE PHYSICIAN ATTEMPTED TO REMOVE AND REINSERT THE BUTTON SEVERAL TIMES, BUT THE ISSUE PERSISTED. A NEW PACK OF BUTTONS OF THE SAME TYPE WAS THEN OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301386 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TEN ORCA VALVES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR THE TREATMENT OF GERD ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE RED SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION AFTER INSERTION. THE PHYSICIAN ATTEMPTED TO REMOVE AND REINSERT THE BUTTON SEVERAL TIMES, BUT THE ISSUE PERSISTED. A NEW PACK OF BUTTONS OF THE SAME TYPE WAS THEN OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301371 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TEN ORCA VALVES WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE FOR THE TREATMENT OF GERD ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE RED SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION AFTER INSERTION. THE PHYSICIAN ATTEMPTED TO REMOVE AND REINSERT THE BUTTON SEVERAL TIMES, BUT THE ISSUE PERSISTED. A NEW PACK OF BUTTONS OF THE SAME TYPE WAS THEN OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301365 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED FOR COLON DURING COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026 FOR THE TREATMENT OF POLYPS. DURING THE PROCEDURE THE SUCTION BUTTON STUCK. 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 25301363 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED FOR COLON DURING COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026 FOR THE TREATMENT OF POLYPS. DURING THE PROCEDURE THE SUCTION BUTTON STUCK. 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 25301353 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION. THE PHYSICIAN REMOVED THE BUTTON, DIP IT IN WATER, AND REINSERT IT; HOWEVER, THE VALVE CONTINUED TO STICK. THE PROCEDURE WAS COMPLETED USING ANOTHER SUCTION BUTTON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301332 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION. THE PHYSICIAN REMOVED THE BUTTON, DIP IT IN WATER, AND REINSERT IT; HOWEVER, THE VALVE CONTINUED TO STICK. THE PROCEDURE WAS COMPLETED USING ANOTHER SUCTION BUTTON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301331 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION. THE PHYSICIAN REMOVED THE BUTTON, DIP IT IN WATER, AND REINSERT IT; HOWEVER, THE VALVE CONTINUED TO STICK. THE PROCEDURE WAS COMPLETED USING ANOTHER SUCTION BUTTON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301329 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION. THE PROCEDURE WAS COMPLETED USING 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 25301328 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION. THE PHYSICIAN REMOVED THE BUTTON, DIP IT IN WATER, AND REINSERT IT; HOWEVER, THE VALVE CONTINUED TO STICK. THE PROCEDURE WAS COMPLETED USING ANOTHER SUCTION BUTTON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301324 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION. THE PHYSICIAN REMOVED THE BUTTON, DIP IT IN WATER, AND REINSERT IT; HOWEVER, THE VALVE CONTINUED TO STICK. THE PROCEDURE WAS COMPLETED USING ANOTHER SUCTION BUTTON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301319 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ORCA VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION. THE PHYSICIAN REMOVED THE BUTTON, DIP IT IN WATER, AND REINSERT IT; HOWEVER, THE VALVE CONTINUED TO STICK. THE PROCEDURE WAS COMPLETED USING ANOTHER SUCTION BUTTON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301311 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED FOR COLON DURING COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026 FOR THE TREATMENT OF POLYPS. DURING THE PROCEDURE THE SUCTION BUTTON STUCK. 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 25301310 ↗
• MalfunctionMay 27, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED DURING EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE SUCTION BUTTON BECAME STUCK IN THE DEPRESSED POSITION DURING THE PROCEDURE. 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 25301308 ↗
• MalfunctionMay 26, 2026Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVE WAS USED FOR COLON DURING COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026 FOR THE TREATMENT OF POLYPS. DURING THE PROCEDURE THE SUCTION BUTTON STUCK. 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 25292432 ↗
• MalfunctionMay 26, 2026Suction Problem; Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORCA VALVES WERE USED DURING MULTIPLE ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY PROCEDURES PERFORMED FOR CONDITIONS INCLUDING GERD, POLYPS, AND ROUTINE SCREENING. DURING A TWO-WEEK EVALUATION PERIOD BEGINNING ON (B)(6) 2026, PHYSICIANS NOTED THAT THE DEVICE'S SUCTION BUTTON INTERMITTENTLY BECAME STUCK IN THE DOWN POSITION, RESULTING IN EXCESSIVELY STRONG SUCTION. THE ISSUE OCCURRED APPROXIMATELY 15 TIMES DURING THE EVALUATION PERIOD. ALL PROCEDURES WERE 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 25286401 ↗