Paramount Mini GPS PMB4-6-14-80Recalls & 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 00821684006399), received between Mar 24, 2017 and Jun 13, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
- Malposition of Device1
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.
InjuryJun 13, 2019Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PHYSICIAN INTENDED WAS USING A PARAMOUNT MINT STENT TO TREAT A SLIGHTLY CALCIFIED, SLIGHTLY TORTUOUS, 95% STENOTIC LESION IN THE PROXIMAL RENAL ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY. THE DEVICE WAS PREPPED PER IFU WITHOUT ISSUE. A 6FR NON-MEDTRONIC SHEATH AND A 0.014 NON-MEDTRONIC GUIDEWIRE WERE USED FOR THE PROCEDURE WITH NO EMBOLIC PROTECTION. THE LESION WAS PRE-DILATED WITH A 3MM A 5MM DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT HOWEVER, RESISTANCE WAS ENCOUNTERED AND EXCESSIVE FORCE APPLIED DURING DELIVERY OF THE DEVICE TO THE LESION. IT WAS REPORTED THAT THE STENT DISLODGED. A SNARE WAS USED TO CAPTURE THE DISLODGED STENT. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8694954 ↗MalfunctionMar 24, 2017Deflation Problem; Deflation Problem
PHYSICIAN WAS ATTEMPTING TO TREAT A LESION WITH PLAQUE, LITTLE CALCIFICATION AND 80% STENOSIS WITH NO TORTUOSITY IN THE RENAL ARTERY USING PARAMOUNT MINI STENT. IT WAS REPORTED THAT BALLOON INFLATION/DEFLATION DIFFICULTIES OCCURRED; THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE. THE LESION WAS PREDILATED. THE PROCEDURE WAS COMPLETED BY DEPLOYING THE STENT. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6430869 ↗
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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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