Dialog+® 710200KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963686338), received between Mar 1, 2018 and Mar 19, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K083460, K963440); 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Calibration Problem; Calibration Problem

  EVENT 4: ACCORDING TO THE EVENT DESCRIPTION: DURING THE INSTALLATION PROCESS OF 42 DIALOG+ HDF ONLINE (EVO) EQUIPMENT (CODE: 7102072) AND DIALOG+ C/ SUP. CARD. BIC (EVO) (CODE: 710200C) IN THE (B)(6), A SIGNIFICANT DEVIATION WAS IDENTIFIED IN THE CALIBRATION PROCESS OF THE MEASURING INSTRUMENTS. WHEN CARRYING OUT THE TESTS, IT WAS OBSERVED THAT FOR A NOMINAL VALUE OF 14.30 MS/CM CONFIGURED IN DIALOG, THE MEASURING INSTRUMENT (B)(6) (MANUFACTURER: IBP, MODEL: HDM97BQ) PRESENTED READINGS CLOSE TO 16.00 MS/CM, SIGNIFICANTLY ABOVE THE ESTABLISHED TOLERANCE OF ±0.1 MS/CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643810 ↗
• MalfunctionMar 19, 2025Calibration Problem; Calibration Problem

  EVENT 7: ACCORDING TO THE EVENT DESCRIPTION: DURING THE INSTALLATION PROCESS OF 42 DIALOG+ HDF ONLINE (EVO) EQUIPMENT (CODE: 7102072) AND DIALOG+ C/ SUP. CARD. BIC (EVO)(CODE:710200C) IN THE (B)(6) HOSPITAL, A SIGNIFICANT DEVIATION WAS IDENTIFIED IN THE CALIBRATION PROCESS OF THE MEASURING INSTRUMENTS. WHEN CARRYING OUT THE TESTS, IT WAS OBSERVED THAT FOR A NOMINAL VALUE OF 14.30 MS/CM CONFIGURED IN DIALOG, THE MEASURING INSTRUMENT EAN0473 (MANUFACTURER: IBP, MODEL: HDM97BQ) PRESENTED READINGS CLOSE TO 16.00 MS/CM, SIGNIFICANTLY ABOVE THE ESTABLISHED TOLERANCE OF ±0.1 MS/CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643807 ↗
• MalfunctionMar 1, 2018Defective Alarm; Defective Alarm

  AS REPORTED BY THE USER FACILITY: REPORTED THE MACHINE WAS ALARMING AT THE END OF A THERAPY WITH VENOUS AND ARTERIAL PRESSURE ALARMS AND AIR WAS NOTICED GOING TO THE PATIENT. THE USER FACILITY ALSO STATED THE AIR LOOKED LIKE FOAM. THE CUSTOMER ALSO STATED IT MAY BE BECAUSE OF THE BLOODLINES AND CLAMPS. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AS A PRECAUTION ONLY. SHE WAS NOT EXHIBITING ANY SIGNS OR SYMPTOMS THAT WARRANTED AN EMERGENCY ROOM VISIT. THE PATIENT WAS OKAY AND WAS DISCHARGED THE SAME DAY TO RETURN TO THE FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7306975 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083460, K963440. One submission often covers many models, so check the product and lot details in each record.

• Z-0872-2022 · Jan 28, 2022 · Terminated
  Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be us
• Z-0873-2022 · Jan 28, 2022 · Terminated
  Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be us
• Z-1532-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis
• Z-1536-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or ch
• Z-1535-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or
• Z-1533-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodial
• Z-1531-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments
• Z-1534-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemo