SOFT-CUF SFT-A1-2ARecalls & reported problems
GE Medical Systems Information Technologies, Inc. · SOFT-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, INTERNATIONAL, SINGLE · 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 00840682107099), received between Apr 26, 2024 and Apr 26, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (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
- Biocompatibility1
Patient problems
- Caustic/Chemical Burns1
- Contact Dermatitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2024Biocompatibility; Biocompatibility
IT WAS REPORTED THAT A PATIENT SUSTAINED A SKIN REACTION TO THE SOFT-CUF NIBP CUFF REQUIRING TREATMENT.
Patient problems: Caustic/Chemical Burns; Contact Dermatitis
MAUDE report 19191973 ↗
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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