Visi-Pro PXB35-10-37-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684036662), received between Sep 1, 2017 and Sep 1, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A VISI-PRO BALLOON EXPANDABLE STENT TO TREAT A SLIGHTLY TORTUOUS 60 MM MID-LEFT SUPERIOR VENA CAVA (SVC) LESION. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE STENT WAS PREPPED PER THE IFU AND A NON-MDT GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. IT WAS REPORTED THAT TWO ¿KISSING STENTS¿ WERE DEPLOYED IN THE SVC ONE DAY PRIOR TO THIS PROCEDURE - A PROTEGE 12 X 60 SELF-EXPANDING STENT FROM THE LEFT SVC AND A 9X60 PROTEGE SELF-EXPANDING STENT FROM THE RIGHT SVC. THE 12X60 PROTEGE STENT WAS REPORTEDLY OCCLUDED DUE TO THE FORMATION OF A CLOT. IT WAS REPORTED THAT PHYSICIAN DECIDED TO USE A VISI-PRO BALLOON-EXPANDABLE STENT TO KEEP THE VESSEL OPEN. THE VISI-PRO STENT WAS UNABLE TO CROSS THROUGH THE PREVIOUSLY DEPLOYED 12X60 PROTEGE STENT. UPON ATTEMPTING TO REMOVE THIS STENT, DIFFICULTY WAS EXPERIENCED CAUSING THE STENT TO COME OFF THE BALLOON INSIDE THE 7 FR SHEATH. THE PHYSICIAN WAS SUCCESSFUL IN REMOVING THE SHEATH AND THE DISLODGED STENT TOGETHER. THE PHYSICIAN THEN USED ANOTHER VISI-PRO BALLOON EXPANDABLE STENT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6837223 ↗

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 · Terminated
  ev3" 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 · Terminated
  ev3" 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