Design Options® 552079Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964675607), received between Apr 10, 2018 and Apr 12, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult To Position” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2018Difficult To Position; Difficult To Position

  AS REPORTED BY THE USER FACILITY: PATIENT WAS IN FOR INDUCED LABOR, C-SECTION. TWO ATTEMPTS AT EPIDURAL CATHETER PLACEMENT RESULTED IN SUBARACHNOID PLACEMENT OF CATHETER - CATHETER MIGRATED "INTER-THECALLY". BODY POSITION, SITTING UPRIGHT LEVEL L2-L3; SAB LOCAL ANESTHETIC 1.6 ML. EPIDURAL REPLACED LEVEL L3-L4. DURING THE LABOR EPIDURAL PROGRESS, THE IV WAS NOT FUNCTIONING, EPHEDRINE 35MG IM GIVEN, IV WAS RESTARTED, NEO 200MCB IV GIVEN, 15 MG EPHEDRINE IV GIVEN. RE-DOSE - BUPIVACAINE 0.5CC .25%, PATIENT WAS COMFORTABLE AFTER RE-DOSE AND BABY WAS DELIVERED SUCCESSFULLY. CATHETER WAS LEFT IN PLACE AND REMOVED NEXT MORNING, TIP WAS INTACT. PATIENT HAD BLOOD PATCH DUE TO SUSPECTED SPINAL HEADACHE. NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 7426598 ↗
• InjuryApr 10, 2018Difficult To Position; Difficult To Position

  AS REPORTED BY THE USER FACILITY: DURING PREPARATION TO PERFORM A C-SECTION - EPIDURAL BOLUSED WITH 8 ML 2% LIDOCAINE INITIALLY. PATIENT RAPIDLY DEVELOPED DIFFICULTY BREATHING AND LOST CONSCIOUSNESS IMMEDIATE RESPIRATORY ARREST, REQUIRING BVM VENT AND EMERGENT INTUBATION ON THE UNIT. PATIENT WAS TAKEN TO OR FOR C-SECTION WITH GENERAL ANESTHESIA, ULTIMATELY EXTUBATED AND TAKEN TO PACU. BABY DID WELL. EPIDURAL CATHETER MIGRATED INTRA-THECALLY RESULTING IN A HIGH SPINAL, CONFIRMED BY LAB EVALUATION OF ASPIRATE. PATIENT EXPERIENCED COMPLICATIONS OF EXTREMITY PARESTHESIA, SEEN BY NEUROLOGIST WHILE IN HOSPITAL AND IS EXPECTED TO RESOLVE # L4-5 NERVE IRRITATION/RADICULOPATHY; URINARY RETENTION - WENT HOME WITH A CATHETER TO BE REMOVED IN A COUPLE OF DAYS; AND POSITIONAL HEADACHES." ANESTHESIOLOGIST DENIES SADDLE DISTRIBUTION OF ANESTHESIA. CONFIRMED A BLOOD PATCH WAS COMPLETED 4 DAYS AFTER THE PROCEDURE. TO DATE, NO FURTHER COMPLICATIONS TO PATIENT HAS BEEN REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage; Headache; Loss of consciousness; Respiratory Distress

  MAUDE report 7419050 ↗