Visi-Pro™ PXB35-10-27-135Recalls & reported problems
Covidien LP · PXB35-10-27-135 STENT VISI PRO 035 V01 · Class 2 · Implant
All models of Visi-Pro (66)
Data updated Oct 18, 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 00643169788022), received between Jan 3, 2020 and Jan 3, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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 18, 2026.
Most reported problems
Device problems
- Device Damaged by Another Device1
- Device Dislodged or Dislocated1
- Entrapment of Device1
- Physical Resistance/Sticking1
- Positioning Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2020Entrapment of Device; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem; Physical Resistance/Sticking; Entrapment of Device; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem; Physical Resistance/Sticking
PHYSICIAN USED TWO VISIPRO STENTS DURING TREATMENT OF A 50MM CALCIFIED LESION IN THE PATIENT¿S RIGHT PROXIMAL COMMON ILIAC ARTERY WITH REPORTED DIAMETER 10MM. SEVERE VESSEL CALCIFICATION IS REPORTED. LESION EXHIBITED 85% STENOSIS. A NON-MEDTRONIC 7FR SHEATH AND NON-MEDTRONIC GUIDEWIRE WERE USED. IFU WAS FOLLOWED. NO DAMAGE TO DEVICE PACKAGING WAS NOTED PRIOR TO USE. NO ISSUES WERE NOTED WHEN REMOVING HE VISIPRO STENTS FROM THE PACKAGING. LESION PRE-DILATION WAS PERFORMED USING A PTA BALLOON (7X40MM). THE DEVICES WERE NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE IS REPORTED TO HAVE BEEN ENCOUNTERED WHEN ADVANCING. IT IS REPORTED THAT THE FIRST STENT DISLODGED PRIOR TO DEPLOYMENT AND THE SECOND STENT SLIPPED OFF THE BALLOON WHEN ATTEMPTING TO REPOSITION. THE SECOND STENT WAS SNARED IN AORTA AND BROUGHT TO THE RIGHT ILIAC ARTERY AND DEPLOYED. THE STENT WAS CRUSHED USING A DELIVERY BALLOON. A NON-MEDTRONIC COVERED STENT WAS THEN USED TO COVER BOTH STENTS. NO FURTHER INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9543885 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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