Visi-Pro™ PXB35-06-27-080Recalls & reported problems
Covidien LP · PXB35-06-27-080 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 00643169787681), received between Feb 20, 2023 and Feb 20, 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
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.
InjuryFeb 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO BALLOON EXPANDABLE STENT. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. A SNARE WAS USED TO REMOVE THE STENT WITH NO HARM REPORTED TO THE PATIENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE, EXCESSIVE FORCE WAS NOT USED. THE PHYSICIAN PREDILATED THE VESSEL AND USED ANOTHER STENT OF THE SAME SIZE TO COMPLETE THE CASE. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 16403760 ↗
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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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