Design Options® 552176Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046955589487), received between Aug 13, 2024 and Oct 10, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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.

• MalfunctionOct 10, 2024Break; Break

  AS REPORTED BY USER FACILITY, IDENTICAL ISSUES AT WEXFORD. WE HAVE ALSO HAD MANY ISSUES WITH INJECTING THROUGH THE CATHETER AFTER PLACEMENT. FACILITY CONTACT WHO REPORTED THAT DURING OB CASES THE TEST DOSE CAN NOT BE DELIVERED AND THAT SOME OF THE CATHETERS ARE SHEARING. SHE REPORTED THAT THE SAME OUTCOME WAS REQUIRED AS NO BROKEN PIECES FELL OFF IN THE PATIENT BUT A NEW KIT WAS NEEDED AND A NEW CATHETER NEEDED TO BE PLACED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 20417803 ↗
• MalfunctionOct 1, 2024

  UNEVENTFUL EPIDURAL PLACED FOR LABOR. AFTER PLACEMENT, UNABLE TO FLUSH CATHETER. CATHETER DEPTH ADJUSTED WITH NO CORRECTION OF PROBLEM. CATHETER HAD TO BE REMOVED, AND NEW CATHETER PLACED. NURSE PERSONALLY FLUSHED THE AFFECTED CATHETER. ALL THREE PORTS FLUSHED WITHOUT DIFFICULTY. CATHETER WILL BE RETURNED TO COMPANY FOR FURTHER EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343679 ↗
• MalfunctionAug 13, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION FX CATHETERS SHEARING AND CANNOT INJECT TEST DOSE. DETAILED INQUIRY DESCRIPTION FX CATHETERS SHEARING AND CANNOT INJECT TEST DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972424 ↗
• MalfunctionAug 13, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION FX CATHETERS SHEARING AND KINKING. DETAILED INQUIRY DESCRIPTION TEST DOSE CAN'T BE DELIVERED FOR 552176 AND SOME CATHETERS SHEARING. 1. WERE ANY PIECES OF THE BROKEN CATHETER RETAINED IN THE PATIENT? NO 2. WAS IMAGING REQUIRED? NO 3. WHAT TYPE OF MEDICAL INTERVENTION(S) WERE REQUIRED? NEW CATHETER/KIT WAS USED 4. ARE YOU ABLE TO PROVIDE THE PATIENT GROUP THAT THE DEVICES WERE BEING ADMINISTERED TO (OB, ORTHO, OR OTHER TYPE OF PATIENT)? OB 5. WHAT WAS THE OUTCOME AND PATIENT STATUS? NEW CATHETER PLACED THE ISSUE AT FORBES WAS NOT PLACING THE CATHETER (INSERTION WAS EASY), BUT RATHER BEING UNABLE TO INJECT THROUGH THE CATHETER ONCE PLACED. ADDITIONALLY, THERE HAS BEEN A CATHETER THAT DISCONNECTED DUE TO EITHER BEING BROKEN R DETACHED AT THE ALLIGATOR CLIP.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19972341 ↗