Relion BP200 Upper Arm Blood Pressure Monitor HEM-741CRELN4Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00681131895408), received between Aug 28, 2018 and Aug 28, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Low Readings” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryAug 28, 2018Low Readings; Low Readings

  THE CONSUMER REPORTED THAT THE UNIT GAVE HIM A LOW BLOOD PRESSURE (BP) READING (140/83 MMHG) ON (B)(6) AND ONE HOUR LATER, THE EMT GOT A READING OF 175/115 MMHG. HE WAS TAKEN TO THE HOSPITAL AND HAD A HEART ATTACK. HE WAS IN THE HOSPITAL FOR 3 TO 5 DAYS AND HE HAD TWO STENTS IMPLANTED. THE CONSUMER STATED HE HAS NO FAITH IN THE PRODUCT. THE CONSUMER STATED THAT HE USES HIS LEFT ARM AND THAT HE IS RELAXED WHEN TAKING HIS BP MEASUREMENT. HE TAKES HIS BP MEASUREMENT AT THE KITCHEN TABLE AND APPLIES THE CUFF TO HIS LEFT ARM. HIS ARM SIZE IS 12 INCHES. THE CONSUMER IS USING RAYOVAC ALKALINE BATTERIES. THE CONSUMER STATED THAT HE DOES NOT FEEL LIKE ANSWERING ANY MORE QUESTIONS. DURING FOLLOWING UP CALL WITH QUALITY ANALYST ON (B)(6) 2018, CONSUMER STATED UNIT READ LOW AROUND 140/83 ON (B)(6) AND HE WENT TO THE HOSPITAL BECAUSE HE WAS NOT FEELING WELL. CONSUMER STATED AT THE ER HIS BP MEASUREMENT WAS 175/115. CONSUMER STATED HE HAD A MASSIVE HEART ATTACK AND WAS ADMITTED FOR 5 DAYS. HE WAS NOT ON BLOOD PRESSURE MEDICATION BEFORE THE EVENT, BUT NOW IS. HE NOW HAS STENTS. HE HAD NO PREVIOUS HISTORY OF HEART ISSUES. HE HAD THE UNIT FOR ABOUT 6 MONTHS AND WAS USING IT EVERY DAY. CONSUMER WAS

  Patient problems: Cardiac Arrest

  MAUDE report 7825116 ↗