Visi-Pro PXB35-09-57-135Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684036617), received between Mar 1, 2019 and Mar 1, 2019 — classified as 2 injuries.

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 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.

• InjuryMar 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO STENT SYSTEM TO TREAT A FIBROUS LESION IN THE MID RIGHT FISTULA EXHIBITING SEVERE TORTUOSITY AND LITTLE CALCIFICATION WITH 90% STENOSIS. NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY), NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT INACCURATE DELIVERY (I.E. STENT DEPLOYED IN UNINTENDED LESION SITE) OCCURRED. THERE WAS SUFFICIENT DISTAL LANDING ZONE, THE LESION WAS NOT PRE-DILATED OR POST DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. THE PROCEDURE WAS COMPLETED BY USING A MAGIC TORQUE WIRE FOR INTERVENTION. STENT WAS NOT ADVANCING THROUGH FISTULA SO ATTEMPTED TO BRING STENT BACK INTO THE SHEATH. AT THAT POINT, THE STENT CAME OFF THE BALLOON. THE ENDS WERE ALREADY FRAYED OUT SO THE PHYSICIAN WAS UNABLE TO PUSH STENT INTO PLACE. DEPLOYED STENT WITH 4MM, 6MM, AND 12MM BALLOONS. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8381383 ↗
• InjuryMar 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A VISI POR STENT SYSTEM TO TREAT A LESION IN THE PROX ILIAC ARTERY ¿ COMMON EXHIBITING MODERATE CALCIFICATION AND TORTUOSITY. NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY), NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. STENT WAS DISLODGED AT THE DISTAL END OF THE SHEATH. DEPLOYED A 4MM VISI PRO STENT PAST THE STENT, INFLATED AND PULLED BACK THE STENT INTO THE SHEATH. PULLED STENT BACK THROUGH THE SHEATH AND SUCCESSFULLY REMOVED FROM THE SHEATH. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8381363 ↗

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