VanishPoint® 24331Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613703243300), received between May 22, 2019 and May 23, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Backflow” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2019Therapeutic or Diagnostic Output Failure

  I WAS STICKING A PATIENT WITH A VANISHPOINT 21 G. I CLICKED THE BUTTON AND BLOOD SHOT OUT THE SIDE ALL OVER MY HAND THAT WAS GLOVED. I HAD TO CHANGE GLOVES BEFORE DOING ANYTHING ELSE WITH PATIENT. MANUFACTURER RESPONSE FOR TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION, VANISHPOINT (PER SITE REPORTER). MFR SENT CLINICAL REP ALONG WITH TERRITORY MANAGER, WILL BE SENDING TRAINERS NEXT WEEK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8635470 ↗
• MalfunctionMay 22, 2019Unintended Ejection

  AFTER INITIATION OF RETRACTION OF SHARP INTO SHARP CHAMBER, BLOOD BACK FLOWED AND LEAKED OUT OF THE CHAMBER. WE HAVE HAD 4 OTHER REPORTS OF THIS ALONG WITH OTHER ISSUES WITH THIS PARTICULAR DEVICE. OTHER ISSUES IS THAT WHEN THE BUTTON IS DEPRESSED TO RETRACT THE SHARP, IT HAS LAUNCHED THE SHARP OUT INTO THE AIR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8631071 ↗
• MalfunctionMay 22, 2019Backflow; Loose or Intermittent Connection; Difficult or Delayed Activation

  THE VANISHPOINT BLOOD COLLECTION SET, 21 GA X 3/4" X 12" REF# 24331 THE HOUSING CAN COME APART EASILY IF DROPPED OR WITH THE SIMPLE USE OF A FINGERNAIL TO SEPARATE. IT IS NOT SEALED. ADDITIONALLY, THE BUTTON THAT MUST BE DEPRESSED IN ORDER TO RETRACT THE SHARP IS EXTREMELY DIFFICULT TO DEPRESS AND REQUIRES MANEUVERING IN ORDER TO ACHIEVE. THE CLINICIANS HAVE REPORTED THAT THE ITEM HAS ALSO HAD BACKFLOW OF BLOOD INTO THE AREA WHERE THERE IS POTENTIAL TO SEPARATE ALONG WITH THE SHARP BECOMING A PROJECTILE UPON DEPRESSING THE RETRACTION LEVER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8631067 ↗