BiCOAG CD-B610LARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00821925039469), received between Mar 12, 2022 and Jun 26, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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-3244-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE HEMOSTATIC PROBE STOPPED WORKING. THE ISSUE WAS FOUND DURING A THERAPEUTIC BLEEDING CASE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337053 ↗
• InjuryJun 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A THERAPEUTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) THE TIP OF THE HEMOSTATIC PROBE BROKE OFF AND LODGED INSIDE THE SCOPE CHANNEL. THE USER PUSHED IT OUT AND IT FELL INSIDE THE PATIENT'S STOMACH. THE FALLEN PIECE WAS NOT RETRIEVED. THE PROCEDURE WAS PROLONGED A FEW MINUTES AND COMPLETED WITH ANOTHER MANUFACTURER'S DEVICE. THERE WAS NO HARM TO THE PATIENT REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: Foreign Body In Patient

  MAUDE report 19567573 ↗
• MalfunctionDec 22, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, THE HEMOSTATIC PROBE'S TIP BROKE OFF. THE ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383869 ↗
• MalfunctionJan 6, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE 10FR COAX HEMOSTATIC PROBE, THE DISTAL END OF THE PROBE BROKE INSIDE THE ENDOSCOPE, WHILE BEING USED IN THE PATIENT. THE ISSUE OCCURRED DURING THE EMERGENCY THERAPEUTIC PROCEDURE (ARREST OF BLEEDING), THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112760 ↗
• MalfunctionJan 4, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE 10FR COAX HEMOSTATIC PROBE, THE DISTAL END OF THE PROBE BROKE INSIDE THE ENDOSCOPE, WHILE BEING USED IN THE PATIENT. THE ISSUE OCCURRED DURING THE EMERGENCY THERAPEUTIC PROCEDURE (ARREST OF BLEEDING), THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098645 ↗
• MalfunctionMay 26, 2022Break; Break

  THE CUSTOMER REPORTED THE 10FR COAX HEMOSTATIC PROBE TIP BROKE. THE DEVICE WAS HELD ON BY A WIRE AND DID NOT FALL OF COMPLETELY. THE EVENT OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE AND THE OPERATION WAS COMPLETED WITH A NON-OLYMPUS DEVICE. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516065 ↗
• MalfunctionMar 12, 2022Break; Break

  THE CUSTOMER¿S OLYMPUS SALES REPRESENTATIVE REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC) ON BEHALF OF THE CUSTOMER, THE 10FR COAX HEMOSTATIC PROBE BROKE OFF WHILE WITHDRAWING IT DURING AN UNKNOWN THERAPEUTIC PROCEDURE. AT THE TIME OF THE EVENT, THE ELEVATOR WAS IN THE UP POSITION. THERE WERE NO REPORTS OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13742088 ↗

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-3247-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
• Z-3245-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
• Z-3246-2026 · Aug 19, 2026 · Open, Classified
  Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
• Z-1481-2024 · Jan 5, 2024 · Open, Classified
  Hemostasis Probe, Model: CD-B622LA