Welch Allyn, Inc. 901044Recalls & reported problems
Welch Allyn, Inc. · CUFF WA SOFT ADULT · 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 00732094188097), received between Sep 14, 2026 and Sep 14, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Deflate” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Deflate1
- Inaccurate Information1
- Material Deformation1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Material Deformation; Inaccurate Information; Failure to Deflate
The customer reported concerns regarding the accuracy of non-invasive blood pressure (NIBP) measurements obtained using disposable FlexiPort soft cuffs. Three days later, the customer provided the following additional information. Reportedly, a patient lost pulses at approximately 0930 and underwent resuscitation efforts. Following placement of an arterial line after the resuscitation, a discrepancy was observed between non-invasive blood pressure (NIBP) cuff readings and arterial line pressure measurements. According to the report, the blood pressure cuff on the patient's arm consistently displayed measurements that were substantially lower than the arterial line readings. As an example, at approximately 1800, the blood pressure cuff reportedly displayed a reading of 64/41 mmHg while the arterial line reading was 105/53 mmHg. The customer further reported that at 1000, 1015, and 1100, the blood pressure cuff continued to display extremely low blood pressure readings when the cuff was not secured around the patient's arm and was reportedly positioned underneath the patient. The customer reported concern that the discrepancy between the NIBP cuff readings and arterial line pressure
Patient problems: Cardiac Arrest
MAUDE report 50753166 ↗
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- 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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