Dialog+® 710200URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964285615), received between Sep 14, 2017 and Sep 14, 2017 — classified as 1 injury.

8 other recalls cover devices cleared under the same FDA submission (K083460); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: 5 MINUTES INTO THE START OF TREATMENT A PATIENT HAS A CARDIAC ARREST. THE PATIENT STATUS HAS NOT BEEN GIVEN BY THE USER FACILITY. THE BIO MED TECHNICIAN STATED WHEN THE TREATMENT ENDED HE WAS ASKED TO TAKE DIALYSATE SAMPLES TO SEND TO THE LAB. WHEN HE GOT TO THE MACHINE IT WAS IN BYPASS AND DID NOT KNOW FOR HOW LONG. HE THEN TESTED THE FUNCTION OF THE BLOOD LEAK DETECTOR FOR PROPER OPERATION AND IT WAS WORKING WITHIN SPECIFICATIONS. THE BIO MED TECHNICIAN INDICATED THEY WOULD RUN A MOCK TREATMENT TO OBTAIN SAMPLES BEFORE AND AFTER THE EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 6864693 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083460. 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-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-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-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-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