Paramount Mini GPS PMB4-6-18-80Recalls & 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 00821684006429), received between Oct 4, 2018 and Oct 4, 2018 — 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.
InjuryOct 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PHYSICIAN USED A PARAMOUNT MINI BALLOON EXPANDABLE STENT SYSTEM DURING TREATMENT OF A TIGHT AND TORTUOUS LESION IN THE PATIENTS RENAL ARTERY. SOME CALCIUM WAS PRESENT. THE IFU WAS FOLLOWED DURING PREP AND USE OF THE DEVICE. AN INFLATION DEVICE WAS ATTACHED BUT NOT USED AS IT IS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO THE LESION. IT IS REPORTED THE DISLODGED STENT WAS REMOVED USING A SNARE. A SECOND PARAMOUNT MINI WAS SUCCESSFULLY DELIVERED TO THE LESION SITE AND DEPLOYED WITHOUT ISSUE. NO PATIENT INJURY WAS REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7933520 ↗
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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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