Visi-Pro™ PXB35-09-57-080Recalls & reported problems
Covidien LP · PXB35-09-57-080 STENT VISI PRO 035 V01 · Class 3 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169787971), received between Jun 12, 2025 and Jun 12, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2025Malposition of Device; Detachment of Device or Device Component; Device Dislodged or Dislocated; Malposition of Device; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING TREATMENT OF A FIBROUS LESION IN THE PROXIMAL LEFT COMMON ILIAC ARTERY USING THE VISI PRO 035 STENT, THE STENT CAME OFF THE BALLOON CATHETER PREMATURELY, RESULTING IN A 30-MINUTE DELAY IN SURGERY. THE LESION MEASURED 55MM IN LENGTH WITH AN ARTERY DIAMETER OF 9MM, AND THE VESSEL EXHIBITED MINIMAL TORTUOSITY AND CALCIFICATION. THE STENT WAS PUSHED FURTHER INTO PLACE USING A BALLOON, AND MORE BALLOONS THAN TYPICALLY REQUIRED WERE USED DUE TO THE DEVICE ISSUE. THE STENT WAS SUCCESSFULLY POSITIONED AS INTENDED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22193530 ↗
Other STENT, ILIAC devices
- Cordis S.M.A.R.T. Control Vascular Stent System C10040MLCordis US Corp. · STENT, ILIAC1 recall3 reports
- Absolute Pro 1012534-100Abbott Vascular Inc. · STENT, ILIAC51 reports
- Cordis S.M.A.R.T. Control Vascular Stent System C09060MLCordis US Corp. · STENT, ILIAC1 recall0 reports
- Protégé™ GPS™ SERB65-09-60-80Ev3, Inc · STENT, ILIAC1 recall0 reports
- Absolute Pro 1012535-100Abbott Vascular Inc. · STENT, ILIAC1 death41 reports
- Omnilink Elite 1012631-39Abbott Vascular Inc. · STENT, ILIAC27 reports
- Omnilink Elite 1012632-29Abbott Vascular Inc. · STENT, ILIAC25 reports
- Omnilink Elite 1012631-59Abbott Vascular Inc. · STENT, ILIAC21 reports
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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