ProGuide Needles 189623-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717213020450), received between Sep 26, 2019 and Sep 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2019Device Damaged Prior to Receipt by User; Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  CUSTOMER REPORTED THAT THEY ORDERED PROGUIDE SHARP NEEDLES FOR PROSTATE BRACHYTHERAPY BUT THEY INSTEAD RECEIVED PROGUIDE ROUND NEEDLES FOR PROSTATE BRACHYTHERAPY. THE PATIENT WAS BLEEDING DURING THE TREATMENT. THE CUSTOMER SUGGESTED A CONNECTION BETWEEN THE BLEEDING AND THE USAGE OF THE PROGUIDE NEEDLES.

  Patient problems: Blood Loss; No Information

  MAUDE report 9123048 ↗