Custom Select Piston Syringe 750375Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741051142), received between Jun 15, 2018 and Jan 20, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gel Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2020Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SYRINGES WERE EMPTY AND DID NOT CONTAIN THE SALINE WATER AS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9608115 ↗
• MalfunctionJun 15, 2018Gel Leak; Leak/Splash; Gel Leak

  IT WAS REPORTED THAT THE PISTON SYRINGE LEAKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7605278 ↗