Design Options® 552147Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046955184071), received between May 2, 2019 and Aug 1, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A PATIENT PULLED ON HER EPIDURAL CATHETER, AND IT BROKE. PHYSICIAN CUT THE CATHETER AND RECONNECTED IT. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8850445 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 3: FACILITY REPORTED FIVE (5) INCIDENTS OF THE CATHETER CONNECTOR OPENING AND DISCONNECTING. THEY ARE USING TAPE. THIS OCCURRED IN THE ACUTE PAIN SERVICES DEPARTMENT. THEY ARE HAVING TO PULL AND REPLACE THE EPIDURAL CATHETER. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574117 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 4: FACILITY REPORTED FIVE (5) INCIDENTS OF THE CATHETER CONNECTOR OPENING AND DISCONNECTING. THEY ARE USING TAPE. THIS OCCURRED IN THE ACUTE PAIN SERVICES DEPARTMENT. THEY ARE HAVING TO PULL AND REPLACE THE EPIDURAL CATHETER. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574116 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 5: FACILITY REPORTED FIVE (5) INCIDENTS OF THE CATHETER CONNECTOR OPENING AND DISCONNECTING. THEY ARE USING TAPE. THIS OCCURRED IN THE ACUTE PAIN SERVICES DEPARTMENT. THEY ARE HAVING TO PULL AND REPLACE THE EPIDURAL CATHETER. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574114 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 2: FACILITY REPORTED FIVE (5) INCIDENTS OF THE CATHETER CONNECTOR OPENING AND DISCONNECTING. THEY ARE USING TAPE. THIS OCCURRED IN THE ACUTE PAIN SERVICES DEPARTMENT. THEY ARE HAVING TO PULL AND REPLACE THE EPIDURAL CATHETER. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574113 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS PER USER FACILITY, EVENT 1: FACILITY REPORTED FIVE (5) INCIDENTS OF THE CATHETER CONNECTOR OPENING AND DISCONNECTING. THEY ARE USING TAPE. THIS OCCURRED IN THE ACUTE PAIN SERVICES DEPARTMENT. THEY ARE HAVING TO PULL AND REPLACE THE EPIDURAL CATHETER. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8574112 ↗