Paramount Mini GPS PMB8-7-14-80Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684006580), received between Oct 15, 2020 and Oct 15, 2020 — classified as 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
- Positioning Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2020Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem
PHYSICIAN WAS ATTEMPTING TO USE A PARAMOUNT MINI BALLOON EXPANDABLE STENT ALONG WITH NON-MEDTRONIC 7FR SHEATH AND 0.014" GUIDE WIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE FIBROUS LESION IN THE RIGHT PROXIMAL RENAL ARTERY WITH 90% STENOSIS. THE VESSEL IS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND 15MM RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE FAILED TO CROSS/POSITION. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DIRECT STENT WITH THE PARAMOUNT MINI; HOWEVER, THE STENT WOULD NOT CROSS THE LESION. PHYSICIAN TOOK A STENT AND BALLOON OUT AND PREDILATED WITH A 3.0 X 15 CORONARY BALLOON. THE STENT WAS NOTED TO NOT BE SECURELY POSITIONED ON THE BALLOON AND THE PHYSICIAN ELECTED TO USE A DIFFERENT PARAMOUNT MINI IN ITS PLACE. THE STENT WAS NOT SECURELY ATTACHED TO THE BALLOON AND WAS NOT REINSERTED IN THE PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITH NO DIFFICULTIES NOTED DURING REMOVAL. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED HOME WITHOUT INJURY. A 3.0X15 CORONARY BALLOON W
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10683710 ↗
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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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