Visi-Pro PXB35-09-57-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684036600), received between Jun 14, 2017 and Jun 14, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

Recent adverse event reports

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

• MalfunctionJun 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN WAS USING ONE VISI PRO BALLOON-EXPANDABLE STENT TO TREAT A MODERATELY CALCIFIED RIGHT PROXIMAL ILIAC ARTERY. THE DEVICE WAS REMOVED FROM THE PACKAGING AND PREPPED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS FELT WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE STENT WAS SUCCESSFULLY PLACED HOWEVER DURING DELIVERY, THE STENT CAME OFF THE BALLOON PREMATURELY. THE PHYSICIAN WAS ABLE TO RECAPTURE THE STENT WITH THE BALLOON AND PLACE AND DEPLOY THE STENT WHERE INITIALLY INTENDED WITHOUT ANY ADVERSE EVEN TO THE PATIENT. THE PHYSICIAN STATED THAT HE FELT IT CAME OFF BECAUSE HE DIDN'T PREDILATE THE LESION SUFFICIENTLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6641191 ↗

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 · 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
• 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