Visi-Pro™ PXB35-05-37-080Recalls & reported problems
Covidien LP · PXB35-05-37-080 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169787612), received between Apr 10, 2024 and Apr 10, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
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.
MalfunctionApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT WITH A 6FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A 20MM CALCIFIED LESION IN THE PATIENT¿S LEFT PROXIMAL COMMON ILIAC ARTERY. LESION EXHIBITED 85% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH AN 4X40 EVER CROSS PTA BALLOON. THE VESSEL WAS NOT POST-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THE STENT DISLODGED DURING USE IN THE PATIENT. THE STENT DOES NOT REMAIN IN THE PATIENT. THE STENT WAS REMOVED SUCCESSFULLY IN TANDEM WITH THE DELIVERY SYSTEM WITHOUT INJURY/INTERVENTION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE LESION WAS PRE-DILATED AND A REPLACEMENT VISIPRO STENT WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19077682 ↗
Other Stents, drains and dilators for the biliary ducts devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 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.
How reports and recalls are matched · Editorial policy · Report an error on this page