BiCOAG CD-B612LARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00821925039476), received between Aug 7, 2019 and Jan 26, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

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

4 other recalls cover devices cleared under the same FDA submission (K123319); they may or may not involve this specific model.

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. Aug 19, 2026Open, Classified

   Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

   Z-3245-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2024

  BICOAG HEMOSTASIS PROBE 10 FR END BROKE IN SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586673 ↗
• MalfunctionApr 20, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THE DEVICE WAS USED FOR A CASE (AN UNSPECIFIED PROCEDURE) AND DURING THE PROCEDURE, THE SHEATH OF BICOAG PROBE WAS FRACTURED AROUND THE SITE OF DUODENUM BEFORE THE USER APPLY THE HEAT ENERGY. THERE WAS NO ADVERSE EVENT REPORTED. NO HARM OR INJURY TO PATIENT WAS REPORTED. NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16778151 ↗
• MalfunctionApr 20, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THE DEVICE WAS USED AT THE OPERATING ROOM (OPERATING THEATRE) AND DURING THE PROCEDURE (AN UNSPECIFIED PROCEDURE), THE SHEATH OF BICOAG PROBE WAS FRACTURED BEFORE THE USER APPLY THE HEAT ENERGY. THERE WAS NO ADVERSE EVENT REPORTED. NO HARM OR INJURY TO PATIENT WAS REPORTED. NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777947 ↗
• MalfunctionApr 20, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THE DEVICE WAS USED FOR A CASE (AN UNSPECIFIED PROCEDURE) AND DURING THE PROCEDURE, THE SHEATH OF BICOAG PROBE WAS FRACTURED AROUND THE SITE OF DUODENUM BEFORE THE USER APPLY THE HEAT ENERGY. THERE WAS NO ADVERSE EVENT REPORTED. NO HARM OR INJURY TO PATIENT WAS REPORTED. NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777425 ↗
• MalfunctionJan 31, 2022Break; Break

  AS REPORTED, WHILE INSERTING THE PROBE IN THE BIOPSY CHANNEL USER FELT RESISTANCE AND WHEN WITHDRAW THE PROBE CAME APART. THE DISTAL PART TIP OF THE DEVICE BROKE. THE ISSUE FOUND DURING AN UNSPECIFIED PROCEDURE. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13402588 ↗
• MalfunctionAug 7, 2019Break; Output Problem

  MEDICAL DEVICE DID NOT FUNCTION AS EXPECTED AND COULD NOT BE USED ON PATIENT - REPLACEMENT BY VENDOR REQUESTED. THE TIP WHICH DELIVERS THE ELECTRICAL CHARGE TO THE PATIENT "WAS NOT INTACT," AND THAT THE DEVICE WOULD NOT WORK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8869340 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123319. One submission often covers many models, so check the product and lot details in each record.

• Z-3244-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.
• Z-3246-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
• Z-3247-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
• Z-1481-2024 · Jan 5, 2024 · Open, Classified
  Hemostasis Probe, Model: CD-B622LA