Visi-Pro PXB35-06-57-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684036358), received between Nov 3, 2017 and Oct 17, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2018Fracture; Fracture

  THE PATIENT HAD AN X-RAY FOR AN UNRELATED ISSUE; IT WAS OBSERVED ON THE X-RAY THAT A PREVIOUSLY IMPLANTED VISI-PRO STENT IN THE LEFT UPPER EXTREMITY VENOUS SYSTEM WAS FRACTURED, PROCEDURE COMPLETED BY DR (B)(6) ((B)(6) 2018). THE VISI-PRO HAD BEEN IMPLANTED TO TREAT A FIBROUS LESION WHICH WAS PRE-DILATED USING A 4X80 BALLOON. THE VISI-PRO WAS IMPLANTED IN THE LEFT PROXIMAL TO TREAT A FIBROUS LESION, ARTERY DIAMETER 6MM THE LESION WAS PRE-DILATED USING A 4X80 BALLOON. THE X-RAY SHOWED A PORTION OF THE STENT HAD MIGRATED TO THE LEFT PULMONARY ARTERY. THE PHYSICIAN REMOVED THE FRACTURED STENT USING A SNARE, PULLING THE FRACTURED PORTION INTO THE SHEATH AND REMOVING AS A UNIT BY DR (B)(6) ((B)(6) 2018). NO INJURY TO THE PATIENT REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7973594 ↗
• MalfunctionNov 3, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  PHYSICIAN WAS USING A VISIPRO BALLON-EXPANDABLE STENT TO TREAT A LESION. IT WAS REPORTED THAT THE STENT WOULD NOT DEPLOY. THE HCP IS OF THE OPINION THE STENT WAS CRIMPED ON TOO TIGHT. THERE WERE NO INTERVENTIONS REQUIRED OR PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7001043 ↗

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