SAM IO Intraosseous Access System IO706-1P-ENRecalls & reported problems
SAM Medical Products · SAM IO - 25mm Needle Assembly - 1 Pack · Class 2
Data updated Oct 18, 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 00822045000285), received between Apr 19, 2024 and Apr 19, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Failure” (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
- Separation Failure1
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.
MalfunctionApr 19, 2024Separation Failure; Separation Failure
A 27 Y/O MALE ENCOUNTERED A POTENTIALLY CRITICAL OCCURRENCE OF A CHRONIC CONDITION WHILE IN A EXTREMELY DIFFICULT LOCATION TO ACCESS BY FIRST RESPONDERS. THE PATIENT WAS EXTRICATED THEN MOVED TO AN AREA WHERE CARE COULD BE PROVIDED. ONCE CARE WAS STARTED A PARAMEDIC ATTEMPTED 3 PERIPHERAL IV'S WITHOUT SUCCESS AND THEN SUCCESSFULLY INSERTED A 25MM SAM IO NEEDLE SET IN LEFT PROXIMAL TIBIA. ONCE THE SAM IO NEEDLE SET WAS INSERTED THE PARAMEDIC WAS UNABLE TO SEPERATE THE STYLET FROM THE CANNULA SO THE IO NEEDLE SET WAS REMOVED RESULTING IN A POTENTIAL DELAY OF PATIENCE CARE. THE PATIENT WAS TRANSPORTED TO A LOCAL HOSPITAL WHERE THE ED STAFF IMMEDIATELY ATTEMPTED PERIPHERAL VASCULAR ACCESS TWO ADDITIONAL TIMES WITHOUT SUCCESS. THE ED PHYSICIAN SIMUTANEOUSLY PREPARED THE PATIENT FOR CENTRAL VENOUS ACCESS WHICH WAS SUCCESSFUL.
Patient problems: Insufficient Information
MAUDE report 19148833 ↗
Other Needle, Hypodermic, Single Lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 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.
How reports and recalls are matched · Editorial policy · Report an error on this page