Paramount Mini GPS PMB8-5-18-80Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684006597), received between Dec 1, 2017 and Dec 1, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
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.
MalfunctionDec 1, 2017Material Deformation; Material Deformation
THE PHYSICIAN WAS ATTEMPTING USE A PARAMOUNT MINI GPS BALLOON-EXPANDABLE STENT TO TREAT A 15MM PLAQUE LESION WITH LITTLE CALCIFICATION IN THE RIGHT PROXIMAL RENAL ARTERY EXHIBITING 90-95% STENOSIS. THE ARTERY WAS 5 MM IN DIAMETER, AND WAS EXTREMELY TORTUOUS. THE ARTERY WAS REPORTED TO HAVE A VERY SIGNIFICANT ANGLE OF ORIGIN OFF THE AORTA. THE PROCEDURE USED A 6 FR NON-MEDTRONIC SHEATH AND A 0.018" NON-MEDTRONIC GUIDEWIRE. THE VESSEL WAS PRE-DILATED USING A NON-MEDTRONIC 3X20 DEVICE AT 8ATMS FOR 45 SEC WHICH WAS THEN INCREASED TO 12 ATMS AND BALLOON RUPTURED BUT WAS REMOVED INTACT. THE PHYSICIAN THEN ATTEMPTED TO USE A 5X18 PARAMOUNT MINI BALLOON-EXPANDABLE STENT WHICH FAILED TO CROSS THE LESION. THERE WAS DIFFICULTY REMOVING THE PARAMOUNT MINI STENT. THE VESSEL WAS THEN PRE-DILATED FOR A SECOND TIME WITH A MDT 4X40 PLUS AT 8 ATMS FOR 60 SECONDS. THE PHYSICIAN EXCHANGED THE WIRES TO NON-MEDTRONIC 0.014". THE PHYSICIAN THEN ATTEMPTED TO USE ANOTHER PARAMOUNT MINI BALLOON-EXPANDABLE 5X14 STENT, WHICH ALSO FAILED TO CROSS THE LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A 5X40 NON-MEDTRONIC PTA BALLOON INFLATED TO 8 ATMS FOR 60 SECONDS. NO PATIENT INJURY WAS REP ORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7077308 ↗
Other CATHETER, BILIARY, DIAGNOSTIC devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page