Integrity INT25018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994798787), received between Feb 12, 2020 and May 6, 2020 — classified as 3 malfunctions.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE INTEGRITY RX CORONARY STENT SYSTEM TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING / ADVANCEMENT. IT WAS STATED THAT THE STENT FAILED TO CROSS THE LESION AND WAS REMOVED. UPON REINSERTION THE STENT WOULD NOT LOAD ONTO THE WIRE. THE STENT STRUTS WERE NO LONGER INTACT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10027912 ↗
• MalfunctionMay 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE INTEGRITY RX CORONARY STENT SYSTEM TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE CATHETER SNAPPED IN 2 PIECES UPON ADVANCING THE DEVICE TO THE LESION. IT WAS STATED THAT THE STENT COULD NOT BE DEPLOYED AND ALL OF THE PRODUCT WAS REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10027673 ↗
• MalfunctionFeb 12, 2020Use of Device Problem; Use of Device Problem

  ONE INTEGRITY RX CORONARY BARE METAL STENT WAS IMPLANTED TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED ONE MONTH AFTER THE EXPIRY DATE. THE DEVICE REMAINS IN THE PATIENT. NO INTERVENTION OR PATIENT INJURY OCCURRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9699184 ↗