Visi-Pro PXB35-08-17-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684036464), received between Oct 25, 2017 and Dec 5, 2018 — classified as 1 injury, 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 18, 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.

• InjuryDec 5, 2018Malposition of Device; Malposition of Device

  PHYSICIAN USED A VISI PRO BALLOON EXPANDABLE STENT DURING TREATMENT OF A 20MM PLAQUE LESION IN THE PATIENT¿S PROXIMAL COMMON ILIAC ARTERY OF DIAMETER 8MM. MODERATE TORTUOSITY AND CALCIFICATION WERE REPORTED. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS CARRIED OUT USING A SIZE 5 PRE-DILATION DEVICE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO EXCESSIVE FORCE WAS USED BUT RESISTANCE WAS EXPERIENCED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED IN VIVO DURING POSITIONING AS THE STENT CAME OFF THE BALLOON. THE STENT WAS DEPLOYED IN THE INTENDED LESION IN THE PATIENTS ILIAC USING ANOTHER PTA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8132386 ↗
• MalfunctionOct 25, 2017Difficult To Position; Detachment of Device or Device Component; Difficult To Position; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A VISI-PRO BALLOON EXPANDABLE STENT TO TREAT A 2 MM PLAQUE LESION WITH MODERATE CALCIFICATION IN THE PROXIMAL CELIAC ARTERY. THE LESION HAD 90% STENOSIS. THE VESSEL WAS 6 MM IN DIAMETER AND MODERATELY TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE PROCEDURE USED A 6X70 SHEATH. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY IN ADVANCING THE DEVICE AND THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO EXCESSIVE FORCE WAS USED. THE VISI-PRO STENT WOULD NOT ADVANCE THROUGH THE LESION AND THE PHYSICIAN IMMEDIATELY PULLED THE STENT BACK INTO THE SHEATH AND THE STENT CAME OFF. IT WAS REPORTED THAT THE UNDEPLOYED STENT WAS TAKEN OUT ALONG WITH THE SHEATH AND THE PROCEDURE WAS COMPLETED USING A NEW 6X90 SHEATH AND A NEW STENT 6X27 VISI-PRO BALLOON EXPANDABLE STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6978921 ↗

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