Cannulaide CA102-0-25Recalls & reported problems
Salter Labs · Cannulaide Size 2 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10607411007160), received between Apr 24, 2024 and Mar 24, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Too Rigid or Stiff1
- Patient Device Interaction Problem1
Patient problems
- Skin Burning Sensation1
- Skin Erosion1
- Skin Tears1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2026Material Too Rigid or Stiff
IT WAS REPORTED, DUE TO THE INCREASED RIGIDITY, THE NEW VELCRO CAUSED (UNSPECIFIED) TRAUMA TO THE BABY. NO ADDITIONAL INFORMATION PROVIDED CONCERNING MEDICAL INTERVENTION AND/OR PATIENT OUTCOME. ADDITIONAL INFORMATION RECEIVED, 11MAR2026 REPORTED, THE PATIENT OUTCOME WAS THE SKIN REDNESS POTENTIALY PROGRESSED TO STAGE 2 SKIN INJURY, WORSE THAN PRIOR REDNESS. NO ADDITIONAL INFORMATION PROVIDED CONCERNING MEDICAL INTERVENTION AND/OR PATIENT OUTCOME.
Patient problems: Skin Burning Sensation
MAUDE report 24683076 ↗InjuryApr 24, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PRODUCT EXTREMELY RIGID. CAUSING SKIN BREAKDOWN.
Patient problems: Skin Erosion; Skin Tears
MAUDE report 19177116 ↗
Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices
- REMstar System One 60 Series REMstar Auto A-Flex, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)117 deaths10,075 reports
- DreamStation DreamStation Auto BiPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)106 deaths5,937 reports
- DreamStation DreamStation Auto CPAP with Humidifier, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)44 deaths5,793 reports
- REMstar System One 60 Series REMstar Auto A-Flex System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)64 deaths5,138 reports
- REMstar System One 60 Series REMstar Pro C-Flex+, w/Humid System One 60 Series USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)65 deaths4,520 reports
- REMstar System One 60 Series REMstar Auto A-Flex w/HT Humid System One 60 Series, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)43 deaths4,149 reports
- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
- DreamStation DreamStation Auto CPAP w/Humidifier, w/Cell, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)86 deaths3,516 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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