Medline DYND11NS14SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888277085794), received between Mar 23, 2026 and Sep 29, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fluid/Blood Leak; Material Rupture; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931979 ↗
• MalfunctionSep 17, 2026Device Misassembled During Manufacturing /Shipping

  It was reported that "all CS of (b)(6) being unusable because the blue drape is visible thus the sterile field is broken."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802563 ↗
• MalfunctionSep 8, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677743 ↗
• MalfunctionSep 8, 2026Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670152 ↗
• MalfunctionMar 23, 2026Material Rupture; Connection Problem

  ACCORDING TO THE CUSTOMER CONTACT, "PREFILLED SYRINGES WERE BREAKING OFF IN THE CATHETER PORT IMMEDIATELY AND BECOMING LODGED AND RENDERING THE CATHETER USELESS." THE CUSTOMER CONTACT REPORTED, "THE INFLATION BALLOON WAS RUPTURING EVEN WHEN A FRACTION OF THE FLUID WAS INJECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662213 ↗