Visi-Pro PXB35-08-57-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684036532), received between Feb 22, 2017 and Jul 12, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 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.

• MalfunctionJul 12, 2018Burst Container or Vessel; Stretched; Stretched

  PHYSICIAN INTENDED TO USE A VISIPRO DEVICE WITH A 7F X 21CM NON-MDT SHEATH AND A 0.035 STIFF ANGLED NON-MEDTRONIC GUIDEWIRE FOR TREATMENT OF A 90% STENOSED CALCIFIED/PLAQUE LESION IN THE PROXIMAL LEFT COMMON ILIAC ARTERY OF DIAMETER 8MM. SLIGHT TORTUOSITY AND MODERATE CALCIFICATION WAS REPORTED. IFU WAS FOLLOWED. DEVICE PREPPED WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. A 6X80 EVERCROSS PRE-DILATION DEVICE WAS USED. THE STENT WAS DEPLOYED WITH NO ISSUES NOTED. THE VISIPRO WAS USED TO POST-DILATE THE STENT TO A SLIGHTLY LARGER DIAMETER. THE BALLOON WAS BRIEFLY INFLATED TO 14 ATM (RATED BURST PRESSURE RBP 12 ATM) FOR APPROXIMATELY ONE SECOND BEFORE DEFLATION AND RE-POSITIONING TO THE LOCATION WHERE THE BURST WAS NOTICED TO OCCUR AT 4 ATM. THE BURST OCCURRED ON THE THIRD INFLATION AS THE INITIAL INFLATION TO DEPLOY THE STENT IS COUNTED AS INFLATION ONE. UPON WITHDRAWAL OF THE BALLOON, THE BALLOON CATHETER BECAME LODGED IN THE SHEATH; AND SUBSEQUENTLY RIPPED APART CAUSING THE SHEATH TO BE EXCHANGED FOR A NEW ONE. NO PORTION OF THE BALLOON IS SUSPECTED TO HAVE REMAINED IN THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7682375 ↗
• InjuryFeb 22, 2017Burst Container or Vessel; Device Dislodged or Dislocated; Material Deformation; Burst Container or Vessel; Device Dislodged or Dislocated; Material Deformation

  THE PHYSICIAN INTENDED TO USE A VISI-PRO STENT DURING PROCEDURE FOR TREATMENT OF THE LEFT MID COMMON ILIAC ARTERY. THE CALCIFIED LESION EXHIBITED LITTLE TORTUOSITY AND MODERATE CALCIFICATION WITH CTO 100% STENOSIS. LESION LENGTH WAS REPORTED AS 50MM AND ARTERY DIAMETER WAS 9MM. A 6F X 90CM SHEATH WAS PLACED IN THE BRACHIAL ARTERY. PHYSICIAN CROSSED THE CTO OF COMMON ILIAC AND EXTERNAL ILIAC WITH A .035 GLIDEWIRE AND .035 CATHETER. PHYSICIAN PREDILATED LESION WITH MULTIPLE INFLATIONS WITH A 6X150 EVERCROSS BALLOON. EMBOLIC PROTECTION WAS NOT USED. PHYSICIAN THEN PLACED AN 8X150X150 EVERFLEX ENTRUST INTO THE EXTERNAL ILIAC AND EXTENDING INTO THE COMMON ILIAC. AN AREA OF APPROXIMATE 9X50MM WAS LEFT AND PHYSICIAN ATTEMPTED TO DEPLOY THE 8X57X135 VISI-PRO STENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO ISSUE WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE PROXIMAL 2/3 OF THE STENT BEGAN TO DEPLOY CORRECTLY. THE DISTAL 1.3 OF THE STENT WAS NOT DEPLO

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem; Stroke/CVA

  MAUDE report 6348641 ↗

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