Paramount Mini GPS PMB8-5-14-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684006566), received between Mar 5, 2019 and Mar 5, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE PARAMOUNT MINI STENT TO TREAT A RIGHT DISTAL LESION IN THE ILIAC ARTERY COMMON OF A PATIENT IN A PROCEDURE. NO DAMAGE NOTED TO PACKAGING NOTED, NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY, DEVICES WAS PREPPED AS PER IFU. IT WAS REPORTED THAT ONE OF THE STENT¿S DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION, IT JUST CAME LOOSE. THE DISLODGED SENT WAS REMOVED USING A SNARE. THE SECOND STENT DISLODGED BUT WAS AND FULLY EXPANDED IN THE EXTERNAL ILIAC ARTERY. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES, EXCESSIVE FORCE WAS NOT USED. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8389447 ↗