VanishPoint® 10311Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00613703103109), received between Nov 27, 2020 and Mar 19, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025

  WHILE ATTEMPTING TO ADMINISTER INTRAMUSCULAR INJECTION, THE 3ML SYRINGE MALFUNCTIONED AND FULL AMOUNT OF MEDICATION WAS NOT ADMINISTERED. THE MEDICATION WAS COMING OUT FROM AROUND THE SPRING LOAD AREA OF SYRINGE AND ONTO NURSES GLOVES WHILE TRYING TO ADMINISTER AND NEEDLE IN ARM OF PATIENT. UNKNOWN HOW MUCH MEDICATION THE PATIENT ACTUALLY RECEIVED. ADDITIONALLY, THE PLUNGER IS VERY DIFFICULT TO PUSH IN, ALMOST REQUIRING 2 THUMBS TO PUSH PLUNGER. COINCIDENTLY, WE ALSO REALIZED THAT THE BLUE CIRCLE ON THESE DEVICES ARE ALSO FLAT OR SOMEWHAT CONCAVE IN APPEARANCE WHEREAS PREVIOUS SYRINGES THE BLUE CIRCLE WAS CONVEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641870 ↗
• MalfunctionMar 19, 2025

  THE PLUNGER IS VERY DIFFICULT TO PUSH IN, ALMOST REQUIRING 2 THUMBS TO PUSH PLUNGER TO ALLOW FOR THE NEEDLE TO RETRACT. COINCIDENTLY, WE ALSO REALIZED THAT THE BLUE CIRCLE ON THESE DEVICES IS ALSO FLAT OR SOMEWHAT CONCAVE IN APPEARANCE WHEREAS PREVIOUS SYRINGES THE BLUE CIRCLE WAS CONVEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641835 ↗
• MalfunctionMar 24, 2023Mechanical Problem; Output Problem

  THE NURSE WENT TO INJECT MEDICATION. SHE PUSHED IN THE PLUNGER, BUT THE RUBBER PART DID NOT ENGAGE, AND MEDICATION DID NOT GO INTO THE PATIENT. ALSO, THE SHARPS PROTECTION DID NOT ENGAGE.

  Patient problems: Insufficient Information

  MAUDE report 16609856 ↗
• MalfunctionMay 11, 2021Fluid/Blood Leak; Defective Device

  NURSE WAS ADMINISTERING MEDICATIONS AND THE MEDICATION SQUIRTED OUT OF THE SYRINGE AND INTO THE AIR. RESIDUAL MEDICATION NOTED IN THE SYRINGE ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805679 ↗
• MalfunctionApr 23, 2021Fluid/Blood Leak

  WHEN ADMINISTERING MEDICATION, THE SYRINGE MALFUNCTIONED, SPRAYING MEDICATION ONTO THE STAFF.

  Patient problems: Chemical Exposure

  MAUDE report 11715646 ↗
• MalfunctionApr 16, 2021Fluid/Blood Leak; Retraction Problem

  NURSE ATTEMPTED TO PUNCTURE THE PATIENT¿S ARM TO ADMINISTER THE INJECTION, THE NEEDLE RETRACTED ON ITS OWN. MEDICATION LEAKED OUT ONTO THE PATIENT¿S ARM.

  Patient problems: Insufficient Information

  MAUDE report 11677692 ↗
• MalfunctionFeb 26, 2021Leak/Splash; Therapeutic or Diagnostic Output Failure

  SYRINGE WITH AUTO-RETRACT NEEDLE MALFUNCTIONED DURING IM ADMINISTRATION FOR PT. MEDICATION LEAKED FROM SYRINGE, LEAVING STAFF UNSURE OF HOW MUCH OF THE MEDICATION PT ACTUALLY RECEIVED.

  Patient problems: Underdose

  MAUDE report 11384696 ↗
• MalfunctionFeb 16, 2021Retraction Problem

  NURSE WAS ADMINISTERING MEDICATIONS TO PATIENT USING THIS SYRINGE. UPON CONTACT WITH THE PATIENTS LEFT DELTOID, THE NEEDLE RETRACTED INTO THE SYRINGE WITHOUT DISPENSING ANY MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11332434 ↗
• MalfunctionDec 1, 2020Defective Device

  THIS IS THE THIRD EVENT IN WHICH THE VANISH POINT RETRACTABLE SYRINGE HAS MALFUNCTIONED AND PATIENT DID NOT RECEIVE ALL THE MEDS.

  Patient problems: Underdose

  MAUDE report 10927256 ↗
• MalfunctionDec 1, 2020Failure to Deliver

  NURSE WAS GIVING MEDICATIONS AND DURING ADMINISTRATION THE MEDICATION WENT BEHIND THE PLUNGER AND PATIENT DID NOT GET ALL THE MEDICATION. THIS IS THE 5TH MALFUNCTION WITH THIS SYRINGE.

  Patient problems: Underdose

  MAUDE report 10927242 ↗
• MalfunctionDec 1, 2020Retraction Problem

  WHILE GIVING EMERGENT MEDICATIONS, THE SYRINGE RETRACTED. THIS RESULTED IN MEDICINE IN SYRINGE AND NOT ALL BEING GIVEN TO PATIENT. THIS IS 4TH SYRINGE MALFUNCTION.

  Patient problems: Missed Dose

  MAUDE report 10927238 ↗
• MalfunctionNov 27, 2020Fluid/Blood Leak

  A RETRACTABLE (VANISH POINT) 3ML SYRINGE WAS USED TO DRAW UP AND ADMINISTER MEDS TO PATIENT. WHEN THE NURSE ADMINISTERED THE MEDS (CONTACT WITH SKIN) THEY SPILLED OVER AND THE PATIENT DID NOT RECEIVE DOSE. THERE WERE TWO SEPARATE EVENTS (2 DIFFERENT PATIENTS) THAT THIS HAPPENED. SYRINGE HIT ARM AND RETRACTED AND SPILLED MEDS.

  Patient problems: Missed Dose

  MAUDE report 10913630 ↗