Design Options® 552175Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046955589463), received between Jun 21, 2021 and Nov 9, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2021Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE FX CATHETER KNOTTED INTO A BOW TIE. THE KNOT WAS OBSERVED UNDER X-RAY AND REQUIRED SURGICAL REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 12778404 ↗
• MalfunctionAug 10, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: END USER REPORTS: CATHETER BROKE. DETAILED INQUIRY DESCRIPTION: THE CATHETER MIGHT HAVE BEEN PULLED ON AND THEN BROKE AND FRAYED. NO INJURY REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12304009 ↗
• MalfunctionJun 21, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: END USER REPORTS, "CATHETER BROKE AT THE SITE OF THE CONNECTOR WHEN DISCONNECTED." TWO POTENTIAL LOTS WERE PROVIDED: LOT NUMBER 0061756354: EXPIRY DATE 01/01/2022; PRODUCTION DATE 11/30/2020. LOT NUMBER 0061763917: EXPIRY DATE 01/01/2022; PRODUCTION DATE 01/27/2021. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036994 ↗
• MalfunctionJun 21, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: END USER REPORTS, "CATHETER BROKE AT THE SITE OF THE CONNECTOR WHEN DISCONNECTED." TWO POTENTIAL LOTS WERE PROVIDED: LOT NUMBER 0061756354: EXPIRY DATE 01/01/2022; PRODUCTION DATE 11/30/2020. LOT NUMBER 0061763917: EXPIRY DATE 01/01/2022; PRODUCTION DATE 01/27/2021. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036948 ↗
• MalfunctionJun 21, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: END USER REPORTS, "CATHETER BROKE AT THE SITE OF THE CONNECTOR WHEN DISCONNECTED." TWO POTENTIAL LOTS WERE PROVIDED: LOT NUMBER 0061756354: EXPIRY DATE 01/01/2022; PRODUCTION DATE 11/30/2020. LOT NUMBER 0061763917: EXPIRY DATE 01/01/2022; PRODUCTION DATE 01/27/2021. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036947 ↗