Optiflo M00511750Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729745242), received between Jan 4, 2017 and Dec 2, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLO HEMOSTASIS CATHETER WAS TO BE USED IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION PROCEDURE PERFORMED ON (B)(6) 2021. AFTER OPENING THE PACKAGE, IT WAS NOTED THAT THE INNER DEVICE PACKAGING WAS DAMAGED AND THE STERILE SEAL WAS COMPROMISED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTIFLO HEMOSTASIS CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919400 ↗
• MalfunctionDec 22, 2020Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem; Unsealed Device Packaging; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLO NEEDLE WAS TO BE USED DURING A PROCEDURE ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING UNPACKING THE OUTER PACKAGE, THE SEALING OF THE PACKAGE HAD BEEN OPENED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 11058626 ↗
• InjuryDec 5, 2020Retraction Problem; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLO HEMOSTASIS CATHETER WAS USED IN THE COLON DURING AN ENTERIC POLYP EXCISION PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING WITHDRAWAL, THE NEEDLE WAS RETRACTED ABNORMALLY AND PART OF THE NEEDLE TIP WAS EXPOSED, WHICH PRICKED THE FINGER OF THE MEDICAL STAFF. THE PATIENT WAS FOUND POSITIVE FOR HEPATITIS B AND THE MEDICAL STAFF IMMEDIATELY INJECTED IMMUNOGLOBULIN FOR EMERGENCY TREATMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTIFLO HEMOSTASIS CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10951734 ↗
• MalfunctionJan 4, 2017Partial Blockage; Partial Blockage

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPTIFLO HEMOSTASIS CATHETER NEEDLE DEVICE WAS DURING AN ENDOSCOPIC SUBMUCOSAL INJECTION PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE DEVICE WAS UNABLE TO INJECT AGENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPTIFLO INJECTION NEEDLE DEVICE . THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6223942 ↗