MagellanRecalls & reported problems across all models

We found 9 models of Magellan by Cardinal Health 200, LLC in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Jun 21, 2017 and Sep 15, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Magellan problems

Magellan models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Magellan 8881833510

  Syringe, Piston
  7 reports
• Magellan 8881833215

  Syringe, Piston
  4 reports
• Magellan 7777850215

  Needle, hypodermic, single lumen
  4 reports
• Magellan 8881833115

  Syringe, Piston
  3 reports
• Magellan 8881833558

  Syringe, Piston
  2 reports
• Magellan 8881833110

  Syringe, Piston
  1 report
• Magellan 8881833310

  Syringe, Piston
  1 report
• Magellan 8881811558

  Needle, Hypodermic, Single Lumen
  1 report
• Magellan 7777850815

  Needle, hypodermic, single lumen
  1 report

Recent Magellan adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fail-Safe Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778231 ↗
• MalfunctionJan 30, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE NEEDLE BROKE. ADDITIONAL INFORMATION RECEIVED ON 30JAN2025 STATED THAT THE NEEDLEPOINT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21279717 ↗
• MalfunctionJul 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE RN WAS ADMINISTERING SUBCUTANEOUS HEPARIN WITH A CARDINAL HEALTH MONOJECT MAGELLAN 3ML 25GX5/8" NEEDLE. THE RN PULLED UP HEPARIN WITH NO ISSUE. AFTER INJECTING THE NEEDLE INTO THE PATIENT, WHILE PUSHING ON THE PLUNGER TO INJECT THE MEDICATION, THE SYRINGE BECAME DISCONNECTED FROM THE NEEDLE, CAUSING HEPARIN TO EXPLODE ALL OVER RATHER THAN INJECTED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644913 ↗
• MalfunctionJun 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A CRACK WAS DISCOVERED WHEN VACCINE LEAKED FROM THE SYRINGE DURING VACCINE PREPARATION. VACCINE WAS PROPERTY DISPOSED OF AND DISCARDED IN APPROPRIATE BIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567497 ↗
• MalfunctionNov 22, 2023Break; Break

  THE CUSTOMER REPORTED THE DEVICES ARE FAULTY AND KEPT BREAKING ON THE SKIN.ADDITIONAL INFORMATION RECEIVED STATED THE NEEDLE ITSELF WAS BREAKING. THIS HAPPENED 3 TO 4 TIMES SO THEY STOPPED USING IT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191838 ↗
• MalfunctionNov 8, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY ECRI, AN ANONYMOUS ECRI MEMBER REPORTED THAT THERE WAS STAFF MEMBER NEEDLE STICK INJURY WITH A USED NEEDLE DUE TO THE SAFETY DOES NOT ENGAGE ALL THE WAY, SO THE TIP OF THE NEEDLE IS STILL EXPOSED. IT WILL CLICK MAKING YOU THINK IT'S LOCKED AND FULLY OVER THE NEEDLE WHEN IT ISN'T. IT IS ALSO EXTREMELY FLIMSY. THE NEEDLE FEELS AS IF THE SAFETY IS FULLY ENGAGED BUT A SMALL PART OF THE NEEDLE REMAINS UNSHEATHED. THEY ALSO NOTICED IF THE SAFETY IS PUSHED FURTHER TO ATTEMPT TO ENGAGE MORE, THE NEEDLE BEGINS TO BEND. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 STATED THAT NO FIRST AID INTERVENTIONS NEEDED, HAND WASH ONLY. LABS WERE ORDERED. BLOOD/BODY FLUID EXPOSURE (BBFE PROTOCOL) INCLUDED RAPID HIV-1, HIV-2, HEP B AND HEP C AND ALL RESULTED NEGATIVE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18097439 ↗
• MalfunctionNov 8, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY ECRI, AN ANONYMOUS ECRI MEMBER REPORTED THAT THE SAFETY DOESN'T ENGAGE ALL THE WAY, SO THE TIP OF THE NEEDLE IS STILL EXPOSED. IT WILL CLICK MAKING YOU THINK IT'S LOCKED AND FULLY OVER THE NEEDLE WHEN IT ISN'T. THEY ARE ALSO EXTREMELY FLIMSY. THE NEEDLES FEEL AS IF THE SAFETY IS FULLY ENGAGED BUT A SMALL PART OF THE NEEDLE REMAINS UNSHEATHED. THEY ALSO NOTICED IF THE SAFETY IS PUSHED FURTHER TO ATTEMPT TO ENGAGE MORE, THE NEEDLE BEGINS TO BEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097413 ↗
• MalfunctionNov 8, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY ECRI, AN ANONYMOUS ECRI MEMBER REPORTED THAT THE SAFETY DOESN'T ENGAGE ALL THE WAY, SO THE TIP OF THE NEEDLE IS STILL EXPOSED. IT WILL CLICK MAKING YOU THINK IT'S LOCKED AND FULLY OVER THE NEEDLE WHEN IT ISN'T. THEY ARE ALSO EXTREMELY FLIMSY. THE NEEDLES FEEL AS IF THE SAFETY IS FULLY ENGAGED BUT A SMALL PART OF THE NEEDLE REMAINS UNSHEATHED. THEY ALSO NOTICED IF THE SAFETY IS PUSHED FURTHER TO ATTEMPT TO ENGAGE MORE, THE NEEDLE BEGINS TO BEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097407 ↗
• MalfunctionNov 8, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY ECRI, AN ANONYMOUS ECRI MEMBER REPORTED THAT THE SAFETY DOESN'T ENGAGE ALL THE WAY, SO THE TIP OF THE NEEDLE IS STILL EXPOSED. IT WILL CLICK MAKING YOU THINK IT'S LOCKED AND FULLY OVER THE NEEDLE WHEN IT ISN'T. THEY ARE ALSO EXTREMELY FLIMSY. THE NEEDLES FEEL AS IF THE SAFETY IS FULLY ENGAGED BUT A SMALL PART OF THE NEEDLE REMAINS UNSHEATHED. THEY ALSO NOTICED IF THE SAFETY IS PUSHED FURTHER TO ATTEMPT TO ENGAGE MORE, THE NEEDLE BEGINS TO BEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097404 ↗
• MalfunctionNov 8, 2023Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY ECRI, AN ANONYMOUS ECRI MEMBER REPORTED THAT THE SAFETY DOESN'T ENGAGE ALL THE WAY, SO THE TIP OF THE NEEDLE IS STILL EXPOSED. IT WILL CLICK MAKING YOU THINK IT'S LOCKED AND FULLY OVER THE NEEDLE WHEN IT ISN'T. THEY ARE ALSO EXTREMELY FLIMSY. THE NEEDLES FEEL AS IF THE SAFETY IS FULLY ENGAGED BUT A SMALL PART OF THE NEEDLE REMAINS UNSHEATHED. THEY ALSO NOTICED IF THE SAFETY IS PUSHED FURTHER TO ATTEMPT TO ENGAGE MORE, THE NEEDLE BEGINS TO BEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097398 ↗
• InjuryAug 18, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THERE WAS A CATARACT EXTRACTION WAS PERFORMED ON (B)(6) 2023, FOLLOWED BY IMPLANT OF THE LENS AS SCHEDULED. AFTER THE IMPLANT OF THE LENS, THE SURGEON WAS GIVEN A 3ML SYRINGE FILLED WITH 3ML OF BSS (BALANCED SALT SOLUTION) WITH A HYDRODISSECTION NEEDLE ATTACHED. THE SURGEON INSERTED THE NEEDLE TO THE INCISION AND IT WAS THEN NOTED THAT THE FLUID CAME OUT OF THE EYE QUICKLY AND THE SYRINGE WAS VISUALIZED BY AN ASSOCIATE TO BE IN THE SURGEON'S HAND WITHOUT THE NEEDLE ATTACHED TO THE SYRINGE, BUT WAS STILL LOCATED IN THE INCISION. THE SURGEON THEN VIEWED THE NEEDLE THROUGH THE MICROSCOPE AND REMOVED IT. THE SURGEON INFORMED THE SURGICAL TEAM THAT THE LENS WOULD NEED TO BE REMOVED AND A VITRECTOMY WOULD NEED TO BE PERFORMED. THE PATIENT SUFFERED A COMPLICATION DUE TO THE CANNULA SHOOTING OFF INTO THE EYE WHILE HYDRATING PARACENTESIS AT THE END OF THE CASE. THE CANNULA DAMAGED CAPSULE AND ZONULES, CAUSING IOL(INTRAOCULAR LENS)/BAG COMPLEX TO DISLOCATE. THE IOL IMPLANT WAS CUT OUT OF THE EYE AND AN ANTERIOR VITRECTOMY WAS PERFORMED. THE PATIENT WAS LEFT APHAKIC. THE INITIAL INVESTIGATION FOLLOWING THIS EVENT DETERMINED THAT THE EVENT WAS DUE TO USER ERROR. HOWE

  Patient problems: Eye Injury; Foreign Body In Patient

  MAUDE report 17575795 ↗
• InjuryApr 21, 2023Break; Fail-Safe Did Not Operate; Break; Fail-Safe Did Not Operate

  THE CUSTOMER REPORTED THAT THE STAFF REVIEWS OF THE SAFETY NEEDLES HAVE NOT BEEN FAVORABLE. THEY STATED THAT THE SAFETY SHIELD IS NOT USER FRIENDLY AND GETS CAUGHT AND BOTH THE NEEDLE AND SAFETY SHIELD ARE VERY FLIMSY AND BEND EXTREMELY EASILY. WHEN THEY PUSH THE COVERING OVER THE NEEDLE USING THE THUMB, FINGER, AND FLAT SURFACE TECHNIQUES, THEY THINK IT¿S COVERED BUT THEY HAVE TO PUSH HARDER TO GET IT TO SNAP SECURELY. THE SAFETY MECHANISM HAS BENT EXPOSING A BROKEN NEEDLE AND THE NEEDLES HAVE BENT WHEN ADMINISTERING AN INTERMUSCULAR SHOT IN THE DELTOID, WHEN PUTTING ON THE SAFETY, AND WHEN ADMINISTERING AND DRAWING UP PRODUCT. WHEN GIVING MULTIPLE SHOTS ON A CHILD, THEY NEED A SAFETY FEATURE THAT WORKS QUICKLY AND EFFECTIVELY EVERY TIME. THEY HAVE HAD SEVERAL NEEDLE STICKS DUE TO THE SAFETY NOT FULLY ENGAGING AND DON¿T WANT TO PUT THEIR PATIENT¿S SAFETY AT HARM. THE EXACT NUMBER OF CLINICIANS THAT HAVE EXPERIENCED NEEDLE STICKS AND THE DETAILS OF EACH EVENT ARE UNKNOWN BUT PER THE CUSTOMER THE TREATMENT PROTOCOL FOR BBPI WAS FOLLOWED INCLUDING BLOOD WORK, FOLLOW UP BLOOD WORK, POSSIBLE PEP (POST-EXPOSURE PROPHYLAXIS) AND UPDATING TETANUS. THE SPECIFICS OF TREATMENT FOR EACH INCID

  Patient problems: Needle Stick/Puncture

  MAUDE report 16792094 ↗
• MalfunctionNov 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE MEDICATION IS COMING OUT THE SIDE OF THE HUB INSTEAD OF THE NEEDLE ITSELF. IT APPEARS THE HUB IS STRIPPED AND NOT ENGAGING PROPERLY TO THE LUER LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758803 ↗
• MalfunctionSep 24, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING IM MEDICATION ADMINISTRATION (LASIX), LIQUID MEDICATION SPRAYED OUT OF NEEDLE HUB. NEEDLE HUB FOUND TO BE CRACKED UPON INSPECTION. UNSURE OF HOW MUCH MEDICATION PATIENT ACTUALLY RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476531 ↗
• MalfunctionJul 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SYRINGE CRACKED UNDER PRESSURE. THE SYRINGE DID NOT CRACK UNTIL THE MEDICATION WAS BEING PUSHED INTO THE MUSCLE. IT CRACKED ONCE PRESSURE WAS APPLIED, AND THIS LED TO A PORTION OF THE MEDICATION LEAKING OUT OF THE CRACK. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15078951 ↗

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