Visi-Pro PXB35-07-17-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684036396), received between Jul 4, 2017 and Sep 16, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2019Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  PHYSICIAN USED A VISI PRO BALLOON EXPANDABLE STENT SYSTEM DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S RIGHT COMMON ILIAC ARTERY. MODERATE CALCIFICATION REPORTED. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. DURING ATTEMPTED REMOVAL THE UNDEPLOYED STENT DISLODGED IN THE PATIENT¿S BRACHIAL ARTERY. THE STENT WAS NOT REMOVED FROM THE PATIENT. THE STENT WAS INFLATED SECURELY IN THE PATIENT¿S BRACHIAL ARTERY. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9069743 ↗
• InjuryOct 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 STENT TO TREAT A PLAQUE LESION WITH MODERATE CALCIFICATION IN THE PROXIMAL RENAL ARTERY. THE LESION RESULTED IN 90% STENOSIS AND THE VESSEL WAS 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 NON-MEDTRONIC SHEATH, 0.035" NON-MEDTRONIC GUIDEWIRE AND A LEFT BRACHIAL APPROACH. NO EMBOLIC PROTECTION WAS USED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE VISI-PRO WOULD NOT ADVANCE THROUGH THE LESION AND THE PHYSICIAN IMMEDIATELY ATTEMPTED TO PULL THE STENT BACK INTO THE SHEATH ONCE HE ENCOUNTERED RESISTANCE. NO EXCESSIVE FORCE WAS USED. THE STENT FELL OFF THE BALLOON CATHETER AND THE PHYSICIAN WAS UNABLE TO PULL IT BACK INTO THE SHEATH. THE PHYSICIAN WAS ABLE TO THREAD A 4X20 PTA BALLOON THROUGH THE STENT AND OPEN IT, ALTHOUGH IT WAS NOT IN THE TARGET AREA. ANOTHER VISI-PRO STENT WAS IMPLANTED AT COVER THE LESION SITE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6978731 ↗
• MalfunctionJul 4, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN INTENDED TO USE A VISI PRO WITH A 6FR. SHEATH AND .035 GUIDEWIRE FOR THE TREATMENT OF A 10MM MODERATELY TORTUOUS, SLIGHTLY CALCIFIED PLAQUE LESION IN PROXIMAL LOCATION IN THE RENAL ARTERY OF DIAMETER 6MM WHICH EXHIBITED 70% STENOSIS. EMBOLIC PROTECTION WAS NOT USED. DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. LESION WAS NOT PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE STENT DISLODGED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS SUCCESSFULLY REMOVED AS THE STENT ONLY PARTIALLY CAME OFF THE BALLOON SO IT WAS ABLE TO BE REMOVED BY REMOVING THE GUIDE CATHETER THAT IT WAS BEING DELIVERED THROUGH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY UP SIZING THE INTRODUCER AND GUIDE AND USING SAME SIZE STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6685304 ↗

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