Visi-Pro PXB35-07-37-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684036426), received between Feb 2, 2018 and Jan 13, 2026 — classified as 2 injuries, 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 4 most recent of 4 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 24053250 ↗
• InjuryOct 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN USED A VISI-PRO BALLOON EXPANDABLE STENT WITH A NON-MEDTRONIC 6F SHEATH AND A 0.035 STIFF GUIDEWIRE, TO TREAT A SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT COMMON ILIAC ARTERY. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. NO EMBOLIC PROTECTION WAS USED. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE TO THE LESION BUT NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOON DELIVERY SYSTEM. SEVERAL ATTEMPTS TO ADVANCE THE BALLOON INTO THE STENT WERE UNSUCCESSFUL. A NEW 7X40 BALLOON WAS ADVANCED AND USED TO DILATE THE STENT AT THE TARGET LESION SITE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969380 ↗
• InjuryMar 23, 2018Premature Activation; Inaccurate Delivery; Premature Activation; Inaccurate Delivery

  THE PHYSICIAN WAS USING ONE VISIPRO DEVICE TO TREAT A SLIGHTLY TORTUOUS FIBROUS LESION, LOCATED IN THE MID RIGHT FEMORAL / FEMORAL BYPASS AREA, EXHIBITING 75% STENOSIS. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND PREPPED PER THE IFU WITH NO ISSUES NOTED. THE LESION WAS NOT PREDILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS ADVANCING THE DEVICE TO THE LESION SITE, THE STENT DEPLOYED AT AN UNINTENDED SITE. THE PHYSICIAN USED A LONGER SHEATH AND DEPLOYED A SECOND STENT IN THE ORIGINAL APPROPRIATE POSITION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7365581 ↗
• MalfunctionFeb 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN WAS ATTEMPTING TO USE A VISI-PRO BALLOON EXPANDABLE STENT TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT PROXIMAL COMMON ILIAC ARTERY LESION EXHIBITING 95% STENOSIS. A NON-MDT GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE IFU WAS FOLLOWED DURING THE PROCEDURE. IT WAS REPORTED THAT AS THE PHYSICIAN ATTEMPTED TO ADVANCE THE DEVICE TOWARDS THE LESION, IT COULD BE SEEN UNDER FLUOROSCOPY THAT THE STENT WAS BEGINNING TO MIGRATE ON THE BALLOON. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE STENT OVER THE WIRE AND THROUGH THE SHEATH WITH NO FURTHER MIGRATION AND NO INJURY TO THE PATIENT. THE PHYSICIAN REPLACED THE DEVICE WITH ANOTHER VISI-PRO STENT AND COMPLETED THE PROCEDURE WITHOUT FURTHER COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7239181 ↗

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