Paramount Mini GPS PMB8-6-14-80Recalls & reported problems
Covidien LP · Balloon-Expandable Biliary Stent System · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684006573), received between Dec 7, 2018 and Mar 5, 2019 — classified as 1 injury, 1 malfunction.
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
Device problems
- Device Dislodged or Dislocated1
- Expiration Date Error1
Patient problems
- No Consequences Or Impact To Patient1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 2 most recent of 2 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 8389451 ↗MalfunctionDec 7, 2018Expiration Date Error; Expiration Date Error
IT WAS REPORTED AN EXPIRED PARAMOUNT MINI WAS IMPLANTED IN THE PATIENT¿S RENAL ARTERY AS THE DATING WASN¿T NOTICED. THE DEVICE WAS PREPPED WITHOUT ISSUE. THE STENT WAS DEPLOYED SUCCESSFULLY. NO ADVERSE EVENT REPORTED FOR THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8141512 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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