Visi-Pro PXB35-06-27-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684036310), received between Mar 24, 2017 and Jan 13, 2026 — classified as 2 malfunctions.

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 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.

• MalfunctionJan 13, 2026Detachment of Device or Device Component

  LIMITED INFORMATION REPORTED THAT DURING THE IMPLANT OF 2 VISIPRO STENTS ABOUT 8 YEARS AGO, A "PIECE OF THE BLADE BROKE OFF" AND HAS NOW MIGRATED THROUGH THE PATIENTS BODY. IT IS NOW BEHIND THEIR LEFT KNEE, BUT THE ORIGINAL POSITION WAS UNKNOWN AND THEY WERE ORIGINALLY TOLD THAT THE FOREIGN OBJECT WOULD NOT MIGRATE PAST THE STENT BUT IT NOW HAS. THE PATIENT DOES NOT REPORT ANY ISSUES ASSOCIATED WITH THIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053294 ↗
• MalfunctionMar 24, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ATTEMPT TO TREAT A LESION IN THE LEFT HYPOGASTRIC ARTERY USING A VISI PRO STENT, THE STENT COULD NOT CROSS THE LESION SUCCESSFULLY. IT WAS REPORTED THAT THE LESION WAS PRE-DILATED AND THAT NO EMBOLIC PROTECTION WAS USED. IT WAS REPORTED TO BE MODERATELY CALCIFIED, 10-15 MM IN LENGTH AND WITH A DIAMETER OF 6MM. THE PHYSICIAN REPORTED ENCOUNTERING RESISTANCE WHILE ADVANCING THE DEVICE AND THAT NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE PHYSICIAN REMOVED THE ENTIRE DELIVERY SYSTEM. DEFORMATION OF STENT WAS NOTED ONCE THE VISI-PRO HAD BEEN REMOVED FROM THE PATIENT AND WAS ON THE TABLE. IT WAS REPORTED THAT THE DEVICE TIP COMPONENT WAS DAMAGED WHILE ATTEMPTING TO DELIVER THE STENT THROUGH THE VESSEL. AN EVERFLEX 7X20MM STENT WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6431024 ↗

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