T2 1822-0010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540197566), received between May 31, 2019 and May 31, 2019 — classified as 1 malfunction.

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

• MalfunctionMay 31, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem

  OUR SALES REP. COMPLAINED THAT IN THE KIT THERE WAS 2 END CUP +15 MM. BUT ACTUALLY OUR KIT ROOM CHECKED (ONCE THE KIT HAS BEEN RETURNED) THAT THE LABELS ON ONE END CUP'S BOX ARE DIFFERENT: ONE OF THEM (THE ONE WITH THE BAR CODE) SHOWS 18220010S LOT K06E4D5, AND THE ONE SMALLER ON THE SIDE OF THE BOX SHOWS 18220015S LOT K0EC9E7. THE PACKAGE IS UNOPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8660745 ↗