Seal® SBC-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 08714729981596), received between Feb 26, 2019 and Aug 11, 2026 — classified as 5 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (36 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Material Fragmentation

  It was reported to Boston Scientific Corporation that an OrcaPod 4 was used during a procedure performed on (b)(6), 2026.During the procedure, the middle section of the biopsy bung has detached and become lodged in the channel port, causing an obstruction in the working channel of the scopes. There were no patient complications reported as a result after 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 50202750 ↗
• MalfunctionJul 9, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BIOPSY CAP DETACHED FROM THE SCOPE WHILE THE BIOPSY FORCEPS WERE BEING WITHDRAWN. AS A RESULT, FLUID LEAKED FROM THE SCOPE UNTIL THE CAP WAS REATTACHED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25773599 ↗
• InjuryMay 14, 2026Material Fragmentation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED FOR THE RECTUM IN A RECTAL POLYP REMOVAL PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF RECTAL POLYP. DURING THE PROCEDURE, THE PHYSICIAN NOTED A SMALL BLACK RUBBER FRAGMENT IN THE COLON. THE FRAGMENT WAS REMOVED WITHOUT ISSUE AND WAS IDENTIFIED AS THE INNER PORTION OF THE ORCA BIOPSY CAP THAT HAD BECOME DETACHED AND FALLEN INTO THE SCOPE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25177201 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, FECAL FLUID BACKFLOW FROM THE SEAL VALVE WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING A DEVICE FROM A DIFFERENT MANUFACTURER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434145 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2025. DURING PLASTIC STENT REPLACEMENT, A SUDDEN AND FORCEFUL LEAKAGE OF BILE OCCURRED FROM THE SEAL BIOPSY VALVE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937544 ↗
• MalfunctionAug 6, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED ON AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE BIOPSY FORCEPS WERE INSERTED THROUGH THE SEAL BIOPSY VALVE, THE SEAL DETACHED FROM THE ENDOSCOPE. THIS RESULTED IN FLUID SPRAYING TOWARD THE PHYSICIAN'S FACE. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726024 ↗
• MalfunctionAug 5, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED ON AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE BIOPSY FORCEPS WERE INSERTED THROUGH THE SEAL BIOPSY VALVE, THE SEAL DETACHED FROM THE ENDOSCOPE. THIS RESULTED IN FLUID SPRAYING TOWARD THE PHYSICIAN'S FACE. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717665 ↗
• InjuryJun 30, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED IN A PROCEDURE ON UNKNOWN DATE. DURING THE PROCEDURE, WHILE INSERTING BIOPSY FORCEPS A SMALL PIECE OF RUBBER DETACHED FROM THE DEVICE AND THEN FELL INSIDE THE PATIENT'S BODY. THE FRAGMENT WAS RETRIEVED BY THE PHYSICIAN USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22360022 ↗
• MalfunctionMar 10, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED FOR THE TREATMENT OF GASTROINTESTINAL (GI) BLEEDING. DURING THE PROCEDURE, THE SEAL BIOPSY CAP POPPED OFF; SPRAYING THE PHYSICIAN WITH BLOOD. IT WAS REPORTED THAT SHE WAS WEARING A PERSONAL PROTECTIVE EQUIPMENT (PPE) AND NO TREATMENTS WERE TAKEN AFTER THIS EVENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT REUSABLE CAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559834 ↗
• InjuryNov 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON OCTOBER 26, 2023 FOR THE TREATMENT OF ESOPHAGEAL DISCOMFORT. DURING THE PROCEDURE, ONCE A BIOPSY FORCEPS WAS PASSED, THEY FOUND A SMALL PIECE OF RUBBER SITTING IN THE ESOPHAGUS. THE DISLODGED PIECE WAS REMOVED WITH A ROTH NET. UPON INSPECTION, IT WAS NOTED THAT THE FOREIGN BODY WAS THE INNER RING OF THE BIOPSY CAP THAT SHEARED OFF. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL SEAL BIOPSY VALVE. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211723 ↗
• InjuryNov 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED IN INITIAL EXAMINATION ON ESOPHAGUS, STOMACH, AND DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, THE CENTER PORTION OF THE VALVE FELL INTO THE PATIENT. THE VALVE WAS REMOVED USING ROTH NET AND THE PROCEDURE WAS COMPLETED USING THE ORIGINAL SEAL BIOPSY VALVE. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211711 ↗
• MalfunctionMay 22, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SEAL BIOPSY CAP LEAKED. IT WAS REPORTED THAT THE CAP LEAKED ONTO PERSONNEL IN THE ROOM BUT NO TREATMENT WAS NEEDED. THE PROCEDURE WAS COMPLETED WITH A NON- BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973656 ↗
• MalfunctionMar 18, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY AND ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SEAL BIOPSY VALVE CAP LEAKED WATER. THERE HAVE HAD NUMEROUS INSTANCES WHEN THE CAPS HAVE LEAKED AND HAVE "SPIT" FLUID OR WATER OUT OF THE TOP OF THE CAP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEAL BIOPSY VALVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569416 ↗
• MalfunctionMar 18, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY AND ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SEAL BIOPSY VALVE CAP LEAKED WATER. THERE HAVE HAD NUMEROUS INSTANCES WHEN THE CAPS HAVE LEAKED AND HAVE "SPIT" FLUID OR WATER OUT OF THE TOP OF THE CAP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEAL BIOPSY VALVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16569388 ↗
• MalfunctionMar 17, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY AND ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SEAL BIOPSY VALVE CAP LEAKED WATER. THERE HAVE HAD NUMEROUS INSTANCES WHEN THE CAPS HAVE LEAKED AND HAVE "SPIT" FLUID OR WATER OUT OF THE TOP OF THE CAP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEAL BIOPSY VALVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16568524 ↗
• MalfunctionMar 17, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY AND ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SEAL BIOPSY VALVE CAP LEAKED WATER. THERE HAVE HAD NUMEROUS INSTANCES WHEN THE CAPS HAVE LEAKED AND HAVE "SPIT" FLUID OR WATER OUT OF THE TOP OF THE CAP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEAL BIOPSY VALVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564084 ↗
• MalfunctionMar 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY AND ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SEAL BIOPSY VALVE CAP LEAKED WATER. THERE HAVE HAD NUMEROUS INSTANCES WHEN THE CAPS HAVE LEAKED AND HAVE "SPIT" FLUID OR WATER OUT OF THE TOP OF THE CAP. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEAL BIOPSY VALVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536598 ↗
• MalfunctionJun 16, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE SEAL BIOPSY VALVE WAS LEAKING AND POPPING OFF FROM THE ENDOSCOPE WHEN THE SLIP TIP SYRINGE WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14717030 ↗
• MalfunctionJun 3, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED ON AN UNKNOWN DATE. DURING USE, THE SEAL CONTINUED TO LEAK AND WAS NOT STABLE ON THE BIOPSY PORT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14592245 ↗
• MalfunctionOct 28, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON OCTOBER 06 2021. DURING THE PROCEDURE, WHEN A RADIAL JAW BIOPSY FORCEPS WAS PASSED DOWN THE BIOPSY CHANNEL, A PIECE OF THE BIOPSY CAP DETACHED AND TRAVELLED DOWN THE SCOPE. IT WAS NOTED THAT NO FRAGMENTED MATERIAL OF THE BIOPSY CAP FELL INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEAL BIOPSY CAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715333 ↗
• MalfunctionOct 28, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN A RADIAL JAW BIOPSY FORCEPS WAS PASSED DOWN THE BIOPSY CHANNEL, A PIECE OF THE BIOPSY CAP DETACHED AND TRAVELLED DOWN THE SCOPE. IT WAS NOTED THAT NO FRAGMENTED MATERIAL OF THE BIOPSY CAP FELL INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEAL BIOPSY CAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715189 ↗
• InjuryJan 11, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AFTER PASSING PEDIATRIC FORCEPS DOWN THE SCOPE CHANNEL THE PHYSICIAN NOTICED A FOREIGN DEBRIS INSIDE THE PATIENT. A NET WAS USED TO RETRIEVE THE FOREIGN MATERIAL. THEY TOOK OFF THE BIOPSY VALVE AND NOTED THAT THE DEBRIS WAS FROM THE BIOPSY VALVE BEING FRACTURED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL SEAL BIOPSY CAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11150070 ↗
• MalfunctionMar 26, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE THE BIOPSY CAP WAS LEAKING FLUID. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL SEAL BIOPSY VALVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9885331 ↗
• MalfunctionMar 20, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY PROCEDURE THAT WAS PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN PULLING OUT A SNARE, THE SEAL BIOPSY VALVE WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEAL BIOPSY VALVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861856 ↗
• MalfunctionMar 20, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SEAL BIOPSY VALVE WAS USED DURING A COLONOSCOPY PROCEDURE THAT WAS PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN PULLING OUT A SNARE, THE SEAL BIOPSY VALVE WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER SEAL BIOPSY VALVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9861831 ↗