Magellan 8881850815Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · Class 2
All models of Magellan (29)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521000605), received between Jun 5, 2017 and Oct 15, 2025 — classified as 1 injury, 12 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (5 reports).
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
- Fail-Safe Problem5
- Device Contaminated During Manufacture or Shipping3
- Fluid/Blood Leak3
- Break1
- Connection Problem1
- Crack1
- Fail-Safe Did Not Operate1
- Incomplete or Inadequate Connection1
Patient problems
- No Consequences Or Impact To Patient4
- No Patient Involvement3
- Needle Stick/Puncture2
- No Clinical Signs, Symptoms or Conditions2
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THE NURSE WAS HANDLING A MAGELLAN HYPODERMIC SAFETY NEEDLE ATTACHED WITH THE GUARD DEPLOYED, WRITER EXPERIENCED A NEEDLE STICK TO THE LEFT THUMB IN SPITE OF THE SAFETY GUARD BEING DEPLOYED. ADDITIONAL INFORMATION RECEIVED ON 14OCT2025 STATED THAT THE NURSE RECEIVED FIRST AID AND WAS MANAGED BY OCC HEALTH. INFORMATION FROM THE EMPLOYEE RECORDS IS NOT AVAILABLE.
Patient problems: Needle Stick/Puncture
MAUDE report 23297155 ↗MalfunctionAug 6, 2025Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED A REPORT OF A SAFETY GUARD BREAKING WHILE BEING USED ON A NURSING UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22733723 ↗MalfunctionFeb 10, 2025Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED A CAREGIVER WAS USING A MAGELLAN HYPODERMIC SAFETY NEEDLE 18G 1X1/2, WHEN SHE NOTICED IT TAKES A LOT OF EFFORT TO FULLY ENGAGE THE SAFETY. SHE STATES "YOU HAVE TO ACTUALLY PUSH UP THE SAFETY PART MANUALLY AND PUSH DOWN TO GET IT TO LOCK INTO PLACE. ALSO, WHEN YOU FIRST OPEN THE PACKAGE THE SAFETY PART WAS ALREADY HALFWAY UP SO YOU HAD TO PUSH IT THE REST OF THE WAY DOWN IN ORDER TO FULLY EXPOSE THE NEEDLE TO DRAW MEDS. NONE OF THE MAS/ATCS THAT USED THEM IN OUR AREA FELT THAT THEY WERE "SAFE" TO USE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21350722 ↗InjuryMay 19, 2021Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THE HEALTH CARE PROVIDER WAS CLOSING THE SAFETY SHIELD ON THE NEEDLE AND THE NEEDLE WENT THROUGH THE SAFETY SHEATH. ADDITIONAL INFORMATION RECEIVED STATED THE HEALTHCARE PROVIDER WAS PRICKED BY THE NEEDLE WHEN IT WENT THROUGH THE SHIELD. THE HAND WAS FLUSHED IMMEDIATELY AND WASHED. NO ADDITIONAL MEDICAL INTERVENTION OR PROCEDURES WILL BE NECESSARY.
Patient problems: Needle Stick/Puncture
MAUDE report 11848046 ↗MalfunctionSep 14, 2020Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection
THE CUSTOMER REPORTED THAT WHEN PLACED ON A SYRINGE, LIQUID IS SPRAYING OUT OF THE PINK CONNECTION PIECE. WHEN SCREWING IT ONTO A SYRINGE, IT DOESN'T SEAT. THE DEVICE WILL SPIN FREE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10532553 ↗MalfunctionJul 31, 2020Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem
THE CUSTOMER REPORTED THAT WHEN THE NEEDLE WAS PLACED ON A SYRINGE, LIQUID IS SPRAYING OUT OF THE PINK CONNECTION PIECE. THE CUSTOMER FURTHER STATED THAT WHEN SCREWING IT ON TO THE SYRINGE, IT DOESN'T SEAT AND THE DEVICE WILL SPIN FREE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10349759 ↗MalfunctionJun 9, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THE CUSTOMER REPORTED THAT THE NEEDLE DOESN¿T LOCK WITHIN THE CAP AFTER USE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10136001 ↗MalfunctionSep 12, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE PRODUCT CRACKED AT THE SYRINGE CONNECTION. THIS CAUSED A LEAKAGE AND WASTED MEDICATION/VACCINATION. ADDITIONAL INFORMATION PROVIDED ON 09-SEP-2019 STATED THIS INCIDENT WAS DISCOVERED UPON DRAWING UP. IT IS UNKNOWN IF THE PATIENT RECEIVED THE FULL DOSE OF MEDICATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9006203 ↗MalfunctionJul 24, 2019Break; Fail-Safe Problem; Break; Fail-Safe Problem
THE CUSTOMER REPORTED THAT UPON ACTIVATION, THE SAFETY SHIELD DETACHED AT THE HINGE. THERE WAS NO HARM TO THE PATIENT OR STAFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8822045 ↗MalfunctionMay 3, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
CUSTOMER STATES: THE STERILE PRODUCT HAS A GREEN PARTICAL INSIDE THE PACKAGING, ON THE NEEDLE.
Patient problems: No Patient Involvement
MAUDE report 7484750 ↗MalfunctionAug 23, 2017Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THE CUSTOMER REPORTS THERE IS A FIBER WRAPPED INSIDE THE NEEDLE.
Patient problems: No Information
MAUDE report 6815203 ↗MalfunctionJul 27, 2017Leak/Splash; Leak/Splash
CUSTOMER AT THE PHARMACY REPORTS: CUSTOMER USES NEEDLE TO INJECT PACLITAXEL INTO A CHEMO MIXTURE. WHEN PLUNGER ROD OF BD SYRINGE IS DEPRESSED, MEDICATION LEAKS OUT OF MEDTRONIC NEEDLE HUB. THE CUSTOMER EXPLAINS THAT COMPOUNDERS PUT MORE PRESSURE ON THE PISTON OF THE SYRINGE, CAUSING MORE PRESSURE BEHIND THE NEEDLE. THIS CAUSES NEEDLE THREADS TO BE STRIPPED, AND NEEDLE/SYRINGE BECOME SEPARATED, AND CAUSE A LEAK.
Patient problems: No Patient Involvement
MAUDE report 6748415 ↗MalfunctionJun 5, 2017Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THE CUSTOMER REPORTED SINGLE NEEDLE FOUND TO BE CONTAMINATED WITH SMALL BLACK PARTICLES WHEN REMOVED FROM PACKAGING. THE PRODUCT WAS NOT USED ON A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 6610870 ↗
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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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