VanishPoint® 10391Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613703103901), received between Aug 9, 2019 and Aug 9, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2019Break; Detachment of Device or Device Component; Material Twisted/Bent

  WE HAVE NOTICED CHANGES IN THE QUALITY OF VANISHPOINT 3 ML 25G X 1" SYRINGES OVER THE PAST YEAR. IN THREE OF OUR OFFICES, NURSES WITH 20-35+ YEARS OF EXPERIENCE HAVE NOTED THE PRE-ATTACHED NEEDLE BENDS, BREAKS OFF AT THE HUB, OR SEEMS DULL AND TAKES EXTRA PRESSURE TO PUNCTURE THE SKIN. ONE NEEDLE HAD NO LEVEL. WE NOTIFIED RETRACTABLE TECHNOLOGIES, INC., AND SENT SYRINGES FROM LOT NUMBER A161204 (EXP 11/28/2021) FOR TESTING. WE RECEIVED A LETTER FROM RETRACTABLE TECHNOLOGIES, AND E-MAIL FROM ONE OF THEIR REPS, ADVISING THAT THE SYRINGES WERE FINE BUT THAT OUR NURSES MAY NEED MORE TRAINING. WE FEEL THAT HAS BEEN A CHANGE IN THE QUALITY OF THE PRODUCT, AND THAT OUR VERY EXPERIENCED IMMUNIZATION NURSES DO NOT NEED FURTHER TRAINING ON USING THE SYRINGES. OUR MEDICAL DIRECTOR ASKED THAT WE SUBMIT THIS IN CASE OTHER AGENCIES HAVE NOTICED QUALITY ISSUES WITH VANISHPOINT SYRINGES. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8883422 ↗