Visi-Pro PXB35-07-27-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684036402), received between Dec 12, 2017 and Dec 12, 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 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.

• MalfunctionDec 12, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A VISI-PRO BALLOON EXPANDABLE STENT TO TREAT A 20-30MM MODERATELY CALCIFIED LESION IN THE LEFT DISTAL COMMON ILIAC ARTERY. THE ARTERY HAD A DIAMETER OF 7MM, WAS MODERATELY TORTUOUS AND HAD 80% STENOSIS. THE PROCEDURE USED A 6 FR NON-MEDTRONIC SHEATH AND A 0.035" NON-MEDTRONIC GUIDEWIRE. THE VISI-PRO STENT WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS PRE-DILATED USING A 4X40 PRE-DILATION DEVICE AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE DEVICE FAILED TO CROSS THE LESION. THE LESION WAS THE FURTHER DILATED USING AN EVERCROSS 4X40 BALLOON. THE SHEATH WAS EXCHANGED FOR ANOTHER 6 FR 30CM SHEATH WHICH WAS ADVANCED PAST THE LESION. THE VISI-PRO STENT WAS REMOVED FROM THE PATIENT¿S BODY AND A DEFORMITY WAS REPORTEDLY VISIBLE ON THE STENT. THE DEFORMITY WAS VISUALIZED ON THE END OF STENT STRUTS AND WAS NOT SEEN PRIOR TO ADVANCEMENT. A NEW VISI-PRO STENT WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7111781 ↗

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