Design Options® 552101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964843822), received between May 11, 2021 and Apr 19, 2022 — classified as 2 injuries, 1 malfunction.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2022Difficult to Remove; Difficult to Remove

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: FX CATHETER BALLED UP IN PT'S BACK, RADIOLOGY HELPED EXTRICATE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140377 ↗
• InjuryMay 11, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CATHETER BROKE TWICE. EVENT 1 DESCRIPTION: CATHETER BROKE INSIDE A PATIENT. MEDICAL INTERVENTION NECESSARY. CATHETER REMOVAL IN THE OPERATING ROOM.

  Patient problems: Foreign Body In Patient

  MAUDE report 11805054 ↗
• InjuryMay 11, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 2: UPON INSPECTION ANOTHER CATHETER OF THE SAME LOT NUMBER BROKE IN A PHYSICIAN'S HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805053 ↗