One-Step™ 00884450012062Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450012062), received between Jun 23, 2021 and Aug 31, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 31, 2021Fracture; Material Separation; Fracture; Material Separation

  THE CUSTOMER REPORTS THAT DURING ABDOMINAL CENTESIS TO DRAIN ASCITES, 1 CENTIMETER OF THE CATHETER TIP BROKE OFF INSIDE THE PATIENT. THE TIP WAS NOT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12396999 ↗
• InjuryJun 23, 2021Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE DRAINAGE OF AN ABCESS, THE CENTESIS CATHETER BROKE AND PART OF THE CATHETER REMAINED IN THE PATIENT. THE 3.5 CM OF CATHETER THAT REMAINED IN THE PATIENT REQUIRED REMOVAL IN THE OR TWO DAYS LATER.

  Patient problems: Foreign Body In Patient

  MAUDE report 12052617 ↗