Visi-Pro PXB35-10-27-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684036655), received between Jul 26, 2018 and Jul 26, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• InjuryJul 26, 2018Migration or Expulsion of Device; Premature Activation; Malposition of Device; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Premature Activation; Malposition of Device

  PATIENT CAME IN FOR A FU CEREBRAL ANGIOGRAM AS AN OUTPATIENT. IT IS REPORTED THERE WAS AN UNSUCCESSFUL STENT DEPLOYMENT IN THE RIGHT SUBCLAVIAN ARTERY WITH SUBSEQUENT MIGRATION AND DEPLOYMENT IN THE RIGHT INTERNAL ILIAC ARTREY AFTER THE STENT DETACHED PREMATURELY. ATTEMPTS WERE MADE. THE STENT REMAINS PATENT. NO EVIDENCE OF FLOW LIMITATION TO THE INTERNAL ILIAC ARTERY AND ITS DISTAL BRANCHES. THE PROCEDURE WAS COMPLETED OTHERWISE WITHOUT ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 7722644 ↗

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