VanishPoint® 10131Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613703101303), received between Jan 23, 2019 and Jun 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026

  RN WAS RESTOCKING THE 1ML VANISHPOINT II SYRINGE PACKAGES FOR THE MED ROOM. THE SYRINGES ARE STOCKED ON THE SUPPLY CART AS STRIPS OF APPROXIMATELY 10. RN WAS SEPARATING THE PACKAGES SO THEY WOULD BE INDIVIDUALLY RESTOCKED IN THE SUPPLY CUPBOARD AND WAS STUCK BY A NEEDLE ON HER LEFT INDEX FINGER. UPON CLOSE INSPECTION OF THE SYRINGE PACKAGES, AS ALL OF THEM APPEARED UNOPENED, IT WAS NOTED THAT A NEEDLE IN ONE SYRINGE PACKAGE WAS NOT PROTECTED BY THE CAP, PROTRUDING OUT OF THE PACKAGING.

  Patient problems: Needle Stick/Puncture

  MAUDE report 25407519 ↗
• MalfunctionJul 30, 2025Break; Infusion or Flow Problem

  FROM STAFF: NURSE MANAGER REPORTS THAT ONE OF THE RNS BROUGHT HER THE NEEDLE AND STATED IT SNAPPED WHEN THEY WERE DRAWING UP HEPARIN. RN DID NOT GET POKED, AND IT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663464 ↗
• MalfunctionOct 17, 2019Retraction Problem

  NURSE NOTED THAT 2 VANISHPOINT TB 1ML 27G 1/2" SYRINGES WERE DIFFICULT TO RETRACT WHILE GIVING IM INJECTIONS (IMMUNIZATIONS) ON 2 DIFFERENT OCCASIONS, WHEN NEEDLE RETRACTED AND SYRINGE PULLED AWAY FROM SKIN IT ACTUALLY GRABBED THE SKIN. NEEDLES DISCARDED - REPORTED TO THE MANUFACTURER ON 10/2, THEY ARE SENDING A CONTAINER TO OBTAIN SAME DEVICE FROM THE SAME LOT USED BY EH NURSE. I WILL SEND TO THEM AS SOON AS I RECEIVE CONTAINER FOR MAILING. MANUFACTURER RESPONSE FOR SYRINGE, ANTISTICK, VANISHPOINT® (PER SITE REPORTER) : THEY ARE SENDING A CONTAINER FOR EVALUATION OF A SYRINGE/NEEDLE FROM THE SAME LOT USED/DEFECTIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9202319 ↗
• MalfunctionJan 29, 2019Therapy Delivered to Incorrect Body Area

  DURING MEDICATION INJECTION, THE DEVICE FAILED AND HEPARIN SHOT BACK INTO THE RN'S EYES. SHE HAD TO USE THE EYE WASH STATION TO GET THE MEDICATION OUT.

  Patient problems: Chemical Exposure

  MAUDE report 8284853 ↗
• MalfunctionJan 23, 2019Retraction Problem

  AFTER MEDICATION WAS GIVEN AND THE PLUNGER WAS PRESSED IN AS FAR AS IT COULD GO, THE NEEDLE DID NOT AUTO-RETRACT INTO THE DEVICE. THE PATIENT OR STAFF MEMBER WERE NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270271 ↗