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Welch Allyn, Inc. 901043 (REF REUSE-12)Recalls & reported problems

Welch Allyn, Inc. · Welch Allyn FlexiPort Blood Pressure Cuff; Size-12 Large Adult, Reusable, No Tubes or Connectors · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00732094066708), received between Mar 2, 2020 and Mar 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Device problems

  • Patient-Device Incompatibility1

Patient problems

  • Anaphylactic Shock1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 2, 2020Patient-Device Incompatibility

    HILLROM/WELCH ALLYN RECEIVED A REPORT FROM THE ACCOUNT STATING AN EMPLOYEE CAME INTO CONTACT WITH A WELCH ALLYN PSS-44 DURASHOCK WITH REUSE-12 BLOOD PRESSURE CUFF AND HAD ANAPHYLACTIC SHOCK, COMPROMISED AIRWAY AND RASH AFTER COMING INTO CONTACT WITH THE DEVICE. THE EMPLOYEE WAS EMERGENTLY TREATED AT THE ACCOUNT'S LOCATION (MEDICAL CLINIC) AND REFUSED TRANSPORT TO THE HOSPITAL. THE EMPLOYEE HAS RECOVERED FROM THE INCIDENT. THE DEVICE WAS LOCATED AT THE ACCOUNT AT THE TIME OF THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Patient problems: Anaphylactic Shock

    MAUDE report 9775386 ↗

Other blood pressure cuff devices

All blood pressure cuff devices →

Sources and updates

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