VanishPoint® 10161Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00613703101600), received between Jul 1, 2020 and Mar 17, 2023 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (8 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 17, 2023Retraction Problem

  DURING ADMINISTRATION OF VACCINE ON A VETERAN, ROUTINE WAS TO RETRACT NEEDLE AS SOON AS VACCINE HAS BEEN ADMINISTERED. WHEN ATTEMPTED TO RETRACT THE NEEDLE AND PUSH ON THE PLUNGER ALL THE WAY, THE NEEDLE DID NOT RETRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573838 ↗
• MalfunctionMar 17, 2023Failure to Advance; Activation, Positioning or Separation Problem

  BEFORE WITHDRAWING THE MEDICATION IN THE SYRINGE, THIS AUTHOR RETRACTED THE PLUNGER. BEFORE INSERTING NEEDLE INTO MEDICATION VIAL TO WITHDRAW MEDICATION, THIS USER NOTED THAT THE SPRING COLLAPSED IN THE BARREL AND DID NOT ADVANCE APPROPRIATELY WHEN AUTHOR ATTEMPTED TO ADVANCE THE PLUNGER UPWARD/FORWARD. SYRINGE WAS NOT UTILIZED FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573837 ↗
• MalfunctionOct 21, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  CUSTOMER REPORTED THAT IMMEDIATELY AFTER REMOVING A RETRACTABLE TECHNOLOGIES VANISHPOINT SYRINGE FROM ITS WRAPPER, THEY SAW LIQUID CONTAINED INSIDE OF THE BARREL OF THE SYRINGE. THE SYRINGE WAS REPORTED AS A TUBERCULIN SYRINGE WITH NEEDLE, VANISHPOINT® 1 ML 25 GAUGE 1 INCH REGULAR WALL RETRACTABLE SAFETY NEEDLE. MANUFACTURER MODEL# 10161, LOT # G210954. ADDITIONAL PRODUCT INFORMATION IS CONTAINED IN THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651366 ↗
• MalfunctionAug 2, 2022Retraction Problem; Retraction Problem

  CUSTOMER REPORTED RECEIVING TWO FAULTY VANISH POINT SYRINGES FROM THE ANCILLARY KITS. THE FIST MALFUNCTION WAS WHEN ONE OF THE NEEDLES WOULD NOT RETRACT EASILY. THE SECOND MALFUNCTION OCCURRED WHEN THE NEEDLE RETRACTED BEFORE THE VACCINE ENTERED THE PATIENT, AND THE VACCINE SQUIRTED ALL OVER THE FATHER'S LEG AND PATIENT'S LEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152599 ↗
• MalfunctionApr 14, 2022Retraction Problem; Retraction Problem

  COMPLAINT REPORTER INDICATED THE FOLLOWING VIA E-MAIL ON 15-MARCH-2022: "THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO'S DON'T RETRACT RELIABLY AND WITH CHILDREN, IT'S NOT SAFE TO RUN THE RISK OF NOT HAVING IT RETRACT AND ACCIDENTLY POKING A CHILD/CAREGIVER OR THE VACCINE ADMINISTRATOR." SIX (6) LOT NUMBERS OF THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO WERE IDENTIFIED BY THE REPORTING SITE AS DEFECTIVE. THE EVENT DATES FOR THE REPORTED LOT NUMBERS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14113610 ↗
• MalfunctionApr 14, 2022Retraction Problem; Retraction Problem

  COMPLAINT REPORTER INDICATED THE FOLLOWING VIA E-MAIL ON 15-MARCH-2022: "THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO'S DON'T RETRACT RELIABLY AND WITH CHILDREN, IT'S NOT SAFE TO RUN THE RISK OF NOT HAVING IT RETRACT AND ACCIDENTLY POKING A CHILD/CAREGIVER OR THE VACCINE ADMINISTRATOR." SIX (6) LOT NUMBERS OF THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO WERE IDENTIFIED BY THE REPORTING SITE AS DEFECTIVE. THE EVENT DATES FOR THE REPORTED LOT NUMBERS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14113570 ↗
• MalfunctionApr 14, 2022Retraction Problem; Retraction Problem

  COMPLAINT REPORTER INDICATED THE FOLLOWING VIA E-MAIL ON 15-MARCH-2022: "THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO'S DON'T RETRACT RELIABLY AND WITH CHILDREN, IT'S NOT SAFE TO RUN THE RISK OF NOT HAVING IT RETRACT AND ACCIDENTLY POKING A CHILD/CAREGIVER OR THE VACCINE ADMINISTRATOR." SIX (6) LOT NUMBERS OF THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO WERE IDENTIFIED BY THE REPORTING SITE AS DEFECTIVE. THE EVENT DATES FOR THE REPORTED LOT NUMBERS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14113551 ↗
• MalfunctionApr 14, 2022Retraction Problem; Retraction Problem

  COMPLAINT REPORTER INDICATED THE FOLLOWING VIA E-MAIL ON 15-MARCH-2022: "THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO'S DON'T RETRACT RELIABLY AND WITH CHILDREN, IT'S NOT SAFE TO RUN THE RISK OF NOT HAVING IT RETRACT AND ACCIDENTLY POKING A CHILD/CAREGIVER OR THE VACCINE ADMINISTRATOR." SIX (6) LOT NUMBERS OF THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO WERE IDENTIFIED BY THE REPORTING SITE AS DEFECTIVE. THE EVENT DATES FOR THE REPORTED LOT NUMBERS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14113548 ↗
• MalfunctionApr 14, 2022Retraction Problem; Retraction Problem

  COMPLAINT REPORTER INDICATED THE FOLLOWING VIA E-MAIL ON 15-MARCH-2022: "THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO'S DON'T RETRACT RELIABLY AND WITH CHILDREN, IT'S NOT SAFE TO RUN THE RISK OF NOT HAVING IT RETRACT AND ACCIDENTLY POKING A CHILD/CAREGIVER OR THE VACCINE ADMINISTRATOR." SIX (6) LOT NUMBERS OF THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO WERE IDENTIFIED BY THE REPORTING SITE AS DEFECTIVE. THE EVENT DATES FOR THE REPORTED LOT NUMBERS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14113530 ↗
• MalfunctionApr 14, 2022Retraction Problem; Retraction Problem

  COMPLAINT REPORTER INDICATED THE FOLLOWING VIA E-MAIL ON 15-MARCH-2022: "THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO'S DON'T RETRACT RELIABLY AND WITH CHILDREN, IT'S NOT SAFE TO RUN THE RISK OF NOT HAVING IT RETRACT AND ACCIDENTLY POKING A CHILD/CAREGIVER OR THE VACCINE ADMINISTRATOR." SIX (6) LOT NUMBERS OF THE 1ML VANISHPOINT SYRINGE/NEEDLE COMBO WERE IDENTIFIED BY THE REPORTING SITE AS DEFECTIVE. THE EVENT DATES FOR THE REPORTED LOT NUMBERS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14113508 ↗
• MalfunctionMar 9, 2022Microbial Contamination of Device; Microbial Contamination of Device

  CUSTOMER REPORTED THAT ON (B)(6) 2022, UPON INSPECTING THE SYRINGES, MOLD AND CONDENSATION WERE DISCOVERED INSIDE THE SEALED, PACKAGED SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13714676 ↗
• MalfunctionMar 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THAT THE VANISH POINT SYRINGE IS FAULTY. WHILE THE NURSE WAS PUSHING DOWN ON THE PLUNGER OF THE SYRINGE, ALL OF THE CONTENTS LEAKED OUT OF THE SIDES OF THE SYRINGE AND LANDED ONTO THE PATIENT'S ARM.

  Patient problems: Chemical Exposure

  MAUDE report 13670962 ↗
• MalfunctionFeb 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  CALLER REPORTED VANISHPOINT 1ML 25G X 1 INCH SYRINGE LEAKED WHILE ADMINISTERING TO 6 YEAR OLD CHILD. HEALTHCARE PROVIDER WAS UNSURE IF PATIENT NEEDED TO BE VACCINATED AGAIN. WE CONTACTED THE REPORTER BY PHONE ON 07-JAN-2022 AND 25-JAN-2022 TO OBTAIN FURTHER DETAILS. THE MANUFACTURER'S NAME WAS PROVIDED, BUT THE LOT NUMBER COULD NOT BE PROVIDED BY THE REPORTER.

  Patient problems: Insufficient Information

  MAUDE report 13453535 ↗
• MalfunctionDec 21, 2021Leak/Splash; Leak/Splash

  REPORTER CALLED ABOUT PFIZER-BIONTECH COVID-19 VACCINE FOR THE ORANGE CAP PRESENTATION. ONE OF HIS VACCINATORS VACCINATED A PATIENT AND SOME OF THE DOSE LEAKED OUT. HE SAID THAT HE ISN'T SURE BUT IT MIGHT HAVE BEEN A PROBLEM WITH THE NEEDLE. HE SAID THAT HE IS NOT SURE HOW MUCH THE PATIENT GOT, BUT HE THINKS THAT THE PATIENT RECEIVED LESS THAN HALF OF THE RECOMMENDED DOSE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13051228 ↗
• InjuryJul 1, 2020Entrapment of Device

  REPORTER STATED NEEDLE WAS MISSING OUT OF SYRINGE AFTER INJECTION WAS ADMINISTERED TO PATIENT (REPORTER'S HUSBAND). REPORTER STATED DOCTORS ARE HAVING A HARD TIME LOCATING THE NEEDLE AND THE PATIENT HAS TO HAVE SURGERY TO REMOVE NEEDLE. PATIENT IS CURRENTLY IN PAIN AND FEELING UNCOMFORTABLE. PATIENT CAN FEEL THE NEEDLE IN HIS LEFT BUTTOCK.

  Patient problems: Device Embedded In Tissue or Plaque; Discomfort; Pain

  MAUDE report 10224249 ↗