NIO NIO-IRecalls & reported problems
WaisMed Ltd · The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290008325066), received between Dec 21, 2023 and Dec 21, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Flush” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Flush1
- Infusion or Flow Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 21, 2023Difficult to Flush; Infusion or Flow Problem; Difficult to Flush; Infusion or Flow Problem
TEXT COPIED FROM INFORMATION RECEIVED FROM CUSTOMER QUESTIONNAIRE IN HANDWRITING ON 01 NOVEMBER 2023: "SAVED TO CODE CRITICAL IN ED, IN RESPIRATORY DISTRESS DUE TO OVERDOSE OF SEIZURE MEDICATION FROM THE NEW ADOPTING PARENT, MULTIPLE ATTEMPTS FROM PIV"S WERE UNSUCCESSFUL. ED MD AND VAT BOTH TRIED NIO INFANT IO'S BOTH WERE ABLE TO GET BLOOD RETURN BUT WERE NOT ABLE TO FLUSH BOTH. SINCE THIS INSERT GOES BILATERALLY ONLY WITH DOWNWARD PRESSURE ON A LYE OLD, WE FELT THIS PRODUCT COULD POTENTIALLY HYPER EXTEND OR BREAK THE LEG OF THE CHILD BEFORE PUNCTURING THE BONE DID NOT FLUSH WHEN PRODUCT WAS BILATERALLY. FINALLY CORRECTLY INSERTED IT." ON (B)(6) A TELEPHONE CONFERENCE WAS HAD WITH SUSO AND THE CUSTOMER. AT THAT TIME THE CUSTOMER DISCLOSED THAT THE PATIENT EXPIRED ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 18371583 ↗
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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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