Visi-Pro PXB35-09-37-080Recalls & reported problems
Covidien LP · Balloon-Expandable Biliary Stent System · Class 2 · Implant
All models of Visi-Pro (66)
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 00821684036587), received between Mar 29, 2017 and Mar 29, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K061566); they may or may not involve this specific model.
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.
MalfunctionMar 29, 2017Material Deformation; Material Deformation
PHYSICIAN ATTEMPTED TO TREAT PATIENT AT THE RIGHT, PROXIMAL COMMON ILIAC ARTERY USING A VISI-PRO STENT. LESION TYPE WAS CALCIFIED WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. ARTERY DIAMETER WAS 9 MM AND LESION LENGTH WAS 30 MM. A 0.035" GUIDEWIRE WAS USED DURING PROCEDURE. IT IS REPORTED THAT STENT DEFORMED IN VIVO DURING DELIVERY THROUGH THE VESSEL. PHYSICIAN STATED THE LESION WAS HIGHLY CALCIFIED. PROCEDURE WAS COMPLETED USING A SECOND VISI-PRO STENT OF THE SAME SIZE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6442871 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K061566. One submission often covers many models, so check the product and lot details in each record.
- Z-1548-2008 · Jul 1, 2008 · Terminatedev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27
- Z-1547-2008 · Jul 1, 2008 · Terminatedev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PX
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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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