Design Options® 555098Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964313578), received between May 2, 2019 and May 2, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 18, 2025Open, Classified

   Potential for the lid of the catheter connector to be in the incorrect position.

   Z-0126-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 4: FACILITY REPORTED THEY HAD MULTIPLE CATHETER CONNECTORS DETACH FROM CATHETERS, BUT HAVE HAD 4 RECENTLY. NO PATIENT INJURIES WERE REPORTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574787 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 1: FACILITY REPORTED THEY HAD MULTIPLE CATHETER CONNECTORS DETACH FROM CATHETERS, BUT HAVE HAD 4 RECENTLY. NO PATIENT INJURIES WERE REPORTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574786 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 2: FACILITY REPORTED THEY HAD MULTIPLE CATHETER CONNECTORS DETACH FROM CATHETERS, BUT HAVE HAD 4 RECENTLY. NO PATIENT INJURIES WERE REPORTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574781 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 3: FACILITY REPORTED THEY HAD MULTIPLE CATHETER CONNECTORS DETACH FROM CATHETERS, BUT HAVE HAD 4 RECENTLY. NO PATIENT INJURIES WERE REPORTED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574780 ↗