Visi-Pro™ PXB35-06-57-080Recalls & reported problems
Covidien LP · PXB35-06-57-080 STENT VISI PRO 035 V01 · Class 2 · Implant
All models of Visi-Pro (66)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169787728), received between Aug 29, 2023 and Aug 29, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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
Device problems
- Device Dislodged or Dislocated1
- Difficult to Advance1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 29, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated
A PHYSICIAN WAS ATTEMPTING TO IMPLANT A VISIPRO STENT FOR THE TREATMENT OF A 55MM CALCIFIED LESION WITH 90% STENOSIS IN THE MID LEFT COMMON ILIAC ARTERY. THE ARTERY WAS 6MM WITH MODERATE CALCIFICATION A MILD TORTUOSITY. A 6FR NON MEDTRONIC SHEATH WAS USED AND A 0.035 X 260CM NON MEDTRONIC GUIDEWIRE. EMBOLIC PROTECTION WAS NOT USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A 4MMX80MM NON MEDTRONIC PRE-DILATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS MET WHEN ADVANCING THE DEVICE. THERE WAS A MODERATE AMOUNT OF CALCIUM IN THE VESSEL. THE PHYSICIAN DECIDED TO PROCEED WITHOUT ADVANCING THE SHEATH AND ATTEMPTED TO PLACE THE STENT. DURING THIS ATTEMPT IT WAS OBSERVED THAT THE STENT HAD BECOME DISLODGED FROM THE DELIVERY SYSTEM AND WHEN THE BALLOON CATHETER WAS REMOVED, THE STENT REMAINED INSIDE OF THE PATIENT. THE STENT APPEARED TO BE DEFORMED. THE DISLODGED STENT REMOVED WAS REMOVED VIA SURGERY. IT WAS REPORTED THAT THE PATIENT WAS STABLE WITHOUT ANY COMPLAINTS OR INJURY. THE PHYSICIAN DECIDED TO DO AN OPEN AORTO-BI-FEM PROCEDURE AS THE PATIENT HAD OTHER DISEASED VESSELS THAT NEEDED TO BE
Patient problems: Insufficient Information
MAUDE report 17642046 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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