Diagnostix™ 6021NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00634782074791), received between Apr 14, 2021 and Apr 14, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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.

• InjuryApr 14, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  END USER WAS USING A MODEL 6021N HOME AUTOMATIC BLOOD PRESSURE MONITOR FOR THE FIRST TIME. THE DEVICE INFLATED TO HIGH PRESSURE (ABOVE 200 MMHG) IN ORDER TO READ THE END USER'S BLOOD PRESSURE. THIS CAUSED SIGNIFICANT DISCOMFORT. THE END USER ATTEMPTED TO TAKE HER BLOOD PRESSURE THREE TIMES, PRESSING THE STOP BUTTON THE FIRST TIME, TRYING TO LOOSEN THE CUFF BEFORE MEASUREMENT THE SECOND TIME, AND STOPPING THE UNIT THE THIRD TIME. END USER REPORTED THAT HER ARM BECAME VERY RED AND SHE HAD DIFFICULTY MOVING HER FOREARM AFTER MEASUREMENT. SHE ALSO REPORTED DIFFICULTY SQUEEZING HER HAND. PHYSICAL THERAPY RELIEVED THESE SYMPTOMS.

  Patient problems: Numbness

  MAUDE report 11663584 ↗