Welch Allyn, Inc. 901043 (REF REUSE-13)Recalls & reported problems
Welch Allyn, Inc. · Welch Allyn FlexiPort Blood Pressure Cuff; Size-13 Thigh, Reusable, No Tubes or Connectors · Class 2
Data updated Oct 16, 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 00732094065749), received between Jul 7, 2022 and Jul 7, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Hematoma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED THE FACILITY " HAD AN INCIDENT WHERE A PATIENT DEVELOPED AN EXTENSIVE HEMATOMA FROM THIGH TO CALF WHICH NEEDED EXTENSIVE TREATMENT AND DEBRIDEMENT." IT IS NOTED THAT THE CUSTOMER UTILIZES MULTIPLE BLOOD PRESSURE MEASUREMENT DEVICES (HILLROM/WELCH ALLYN, AS WELL AS 3RD PARTY VENDOR DEVICES AND COULD NOT CONFIRM THAT A HILLROM DEVICE (BP CUFF WITH VSM 6000 MONITORING DEVICE) WAS USED DURING THIS EVENT. THE CUSTOMER REPORTED THEY HAD 10 HILLROM DEVICES AND 1 3RD PARTY; HOWEVER, THEY COULD NOT STATE WHICH DEVICE WAS BEING USED AND DID NOT NOTE ANY ISSUES OR CONCERNS WITH THE FUNCTIONALITY OF THE DEVICE THIS COMPLAINT HAS BEEN CAPTURED UNDER HILLROM REF # (B)(4).
Patient problems: Hematoma
MAUDE report 14945422 ↗
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-A3-2AGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- Radius VSM 4826Masimo Corporation · blood pressure cuff1 recall0 reports
- ONE-CUF ONE-A2-2A-LGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- ONE-CUF ONE-A3-1BGE Medical Systems Information Technologies, Inc. · Blood Pressure Cuff1 recall0 reports
- Radius VSM 4825Masimo Corporation · blood pressure cuff1 recall0 reports
- Welch Allyn, Inc. 901091Welch Allyn, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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