Visi-Pro PXB35-06-27-135Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684036327), received between Jul 20, 2018 and Jul 20, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Hypersensitivity/Allergic reaction1
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT DEVELOPED ITCHING AND A RASH IN THE AREA OF SKIN CLOSE TO WHERE THE STENT HAD BEEN IMPLANTED, IN THE SUBCLAVIAN, APPROXIMATELY 6 MONTHS EARLIER. THE PATIENT REPORTED THAT SHE HAD/HAS A METAL SENSITIVITY BUT WAS NOT ASKED PRIOR TO THE STENT IMPLANTATION. SHE IS BEING TREATED WITH A PRESCRIPTION OF TRIAMCINOLONE CREAM WHICH SHE MUST APPLY TWICE DAILY.
Patient problems: Hypersensitivity/Allergic reaction; Rash
MAUDE report 7706118 ↗
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-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
- 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
Other CATHETER, BILIARY, DIAGNOSTIC devices
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- 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.
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