Magellan 8881850115Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521000476), received between Jul 21, 2020 and Feb 18, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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
- Fluid/Blood Leak2
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Needle Stick/Puncture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY INJECTED DEPOT TO RIGHT VENTRO-GLUTEAL. NEEDLE APPEARED TO BE FAULTY AS SOME OF THE MEDICATION WAS LEAKING OUT FROM THE DEVICE BEFORE ENTERING THE LUMEN OF THE NEEDLE AS THE MEDICATION WAS BEING PUSHED THROUGH. THEY WERE UNABLE TO DETERMINE HOW MUCH DRUG WAS ACTUALLY RECEIVED BY PATIENT AND HOW MUCH HAD LEAKED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21394102 ↗MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A HYPODERMIC NEEDLE WAS FOUND TO BE FAULTY MID-PROCEDURE. PATIENT WAS HAVING IM DEPOT INJECTION, NEEDLE INSERTED INTO INTRAMUSCULAR TISSUE, PLUNGER DEPRESSED AND FLUID NOTED TO BE LEAKING OUT OF PROXIMAL END OF NEEDLE. PATIENT WAS UNDERDOSED AS A RESULT OF THIS FAULT. FAULTY PRODUCT WAS NOT RETAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21054878 ↗MalfunctionJul 21, 2020Material Protrusion/Extrusion
AFTER GIVING IM INJECTION, RN CLOSED THE SAFETY CAP OF THE 21G 1.5 NEEDLE. WHEN DOFFING ISOLATION GOWN THE NEEDLE CAME THROUGH THE END OF THE SAFETY CAP AND PUNCTURED LEFT BICEP. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Needle Stick/Puncture
MAUDE report 10307520 ↗
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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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