Paramount Mini GPS PMB4-6-21-80Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684006450), received between Dec 15, 2017 and Dec 15, 2017 — 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
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PHYSICIAN WAS ATTEMPTING TO USE A PARAMOUNT MINI BALLOON-EXPANDABLE STENT TO TREAT A 14MM SEVERELY CALCIFIED LESION IN THE RIGHT PROXIMAL RENAL ARTERY. THE ARTERY WAS 6 MM IN DIAMETER, MODERATELY TORTUOUS AND HAD 80% STENOSIS. THE PROCEDURE USED A 6 FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC 0.024" GUIDEWIRE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS PRE-DILATED USING A 3X20 PRE-DILATION DEVICE. THE PHYSICIAN ENCOUNTERED RESISTANCE ADVANCING THE PARAMOUNT MINI, NO EXCESSIVE FORCE WAS USED. THE STENT WOULD NOT CROSS THE LESION. STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY AND THE STENT WAS REMOVED USING A GOOSENECK SNARE. THE CASE WAS ABORTED AND WILL BE RESCHEDULED FOR AN ATTEMPT TO REACH THE LESION THROUGH ARM ACCESS. NO PATIENT INJURY WAS REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7123450 ↗
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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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