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
- Medline MDS9380Medline Industries, Inc. · blood pressure cuff108 reports
- ONE-CUF ONE-A2-2AGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall1 report
- ONE-CUF ONE-A3-1BGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- Radius VSM 4825Masimo Corporation · blood pressure cuff1 recall0 reports
- ONE-CUF ONE-P2-1BGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- Welch Allyn, Inc. 901091Welch Allyn, Inc. · blood pressure cuff1 recall0 reports
- Welch Allyn, Inc. 901091Welch Allyn, Inc. · blood pressure cuff1 recall0 reports
- ONE-CUF ONE-A2-2A-LGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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