ProGuide Needles 189637-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717213053748), received between Sep 12, 2025 and Feb 4, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

• InjuryFeb 4, 2026Fracture

  THE CUSTOMER REPORTED THAT A PIECE OF PLASTIC NEEDLE WAS BROKEN OFF INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24257237 ↗
• MalfunctionSep 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE CUSTOMER WAS CONCERNED OF A RISK OF BIOLOGICAL CONTAMINATION AFTER THE CATHETER BROKE INSIDE THE PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038108 ↗