Design Options® 552116Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04046964950254), received between May 2, 2019 and Sep 18, 2026 — classified as 7 malfunctions.

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

2 FDA recall records name this device's identifier, 2 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 ↗

2. Jun 5, 2023Open, Classified

   Kits were assembled with the incorrect Filter Straw.

   Z-2003-2023 · Root cause: Mixed-up of materials/components · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Device Contamination with Chemical or Other Material

  When opening an epidural kit, a hair was noticed under the gauze and on the sterile drape. The kit was closed and the patient did not come in contact with it. A new kit was obtained, and the patient was prepped and draped. Epidural was placed without incident. The contaminated kit was saved for reporting.No Pt Harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817653 ↗
• MalfunctionMay 12, 2025Break; Difficult to Advance; Break; Difficult to Advance

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: CATHETER SHEARING. DETAILED INQUIRY DESCRIPTION UPON CATHETER REMOVAL THE CATHETER APPEARED SHEARED, AND TIP IS MISSING. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22005515 ↗
• MalfunctionOct 30, 2024Break; Difficult to Remove; Break; Difficult to Remove

  AS REPORTED BY USER FACILITY: REGISTERED NURSE (RN) ATTEMPTED TO REMOVE EPIDURAL CATHETER FROM PATIENT'S BACK WHILE PATIENT ON HER SIDE AND MET SIGNIFICANT RESISTANCE. HAD PATIENT CURL AROUND ABDOMEN TO OPEN THE SPINAL SPACE. STILL UNABLE TO REMOVE EPIDURAL CATHETER. RN CALLED ANESTHESIA PROVIDER TO COME EVALUATE. ANESTHESIA PROVIDER'S ATTEMPT TO REMOVE EPIDURAL CATHETER AND ALSO MET SIGNIFICANT RESISTANCE. DUE TO PATIENT NOT HAVING MUCH FEELING IN HER LEGS ANESTHESIA PROVIDER DETERMINED THAT MORE TIME SHOULD BE GIVEN FOR SENSATION TO COME BACK TO PATIENT'S LEGS. 30 MIN LATER ANESTHESIA PROVIDER RETURNED TO PATIENT'S BEDSIDE TO REASSESS PATIENT'S SENSATION IN LEGS. SENSATION HAD IMPROVED AND ANESTHESIA PROVIDER ATTEMPTED TO REMOVE EPIDURAL CATHETER WHILE PATIENT WAS SITTING UP HUNCHED OVER ABDOMEN. ANESTHESIA PROVIDER UNABLE TO REMOVE EPIDURAL CATHETER. HAS PATIENT GET ONTO HANDS AND KNEES AND WAS ABLE TO REMOVE EPIDURAL CATHETER AT THIS POINT, BUT THE TIP OF THE CATHETER DID NOT COME OUT. THE CATHETER APPEARED TO HAVE UNCOILED WHERE IT BROKE OFF AND ANESTHESIA PROVIDER ATTEMPTED TO REMOVE THE REST OF THE CATHETER BUT WAS UNSUCCESSFUL. ANESTHESIA PROVIDER DETERMINED THAT PATIENT WA

  Patient problems: Foreign Body In Patient

  MAUDE report 20567771 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 4: FACILITY REPORTED CATHETER CONNECTORS ARE DECLASPING. ABOUT 4 TRAYS HAVE BEEN AFFECTED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574593 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 2: FACILITY REPORTED CATHETER CONNECTORS ARE ENCLASPING. ABOUT 4 TRAYS HAVE BEEN AFFECTED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574592 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 1: FACILITY REPORTED CATHETER CONNECTORS ARE ENCLASPING. ABOUT 4 TRAYS HAVE BEEN AFFECTED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574590 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 3: FACILITY REPORTED CATHETER CONNECTORS ARE ENCLASPING. ABOUT 4 TRAYS HAVE BEEN AFFECTED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574588 ↗