Integrity INT35022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994798589), received between Aug 3, 2017 and Feb 16, 2018 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN INTEGRITY RX CORONARY BARE METAL STENT TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION LOCATED AT THE MID RIGHT CORONARY ARTERY, EXHIBITING 90% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. THE INFLATION DEVICE DID REMAIN IN NEUTRAL POSITION DURING DELIVERY OF STENT. IT WAS DESCRIBED THAT THE STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. A GUIDELINER WAS BEING USED. THERE WAS RESISTANCE WHEN TRYING TO GET THROUGH A PREVIOUSLY DEPLOYED STENT. THE PHYSICIAN DECIDED TO GIVE UP AND REMOVE THE STENT, BUT WHEN THE CATHETER WAS REMOVED IT WAS NOTICED THAT THERE WAS NO STENT ON BALLOON. THE DISLODGED STENT WAS NOT REMOVED AND IMPLANTED IN THE PATIENT INSIDE ANOTHER STENT. A BALLOON WAS INSERTED AND USED TO EXPAND THE STENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7276144 ↗
• InjuryAug 3, 2017Device Expiration Issue; Device Expiration Issue

  THE PHYSICIAN INTENDED TO USE AN INTEGRITY BARE METAL STENT TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) WITH 90% STENOSIS. NO OTHER ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED, WITH NO ISSUES FOUND. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PREDILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE BUT THE STENT WAS USED PAST ITS EXPIRATION DATE. THE HOSPITAL CARRIES CONSIGNMENT OF INTEGRITY AND CURRENTLY DO NOT HAVE A SIGNED CONSIGNMENT AGREEMENT. IT WAS REPORTED THAT ROUTINE EXPIRATION CHECKS ARE CARRIED OUT AT THE ACCOUNT BUT MAY HAVE NOT HAVE BEEN THE CASE FOR THIS EVENT. NO ISSUES WERE NOTED DURING THE PROCEDURE. POST PROCEDURE THE PATIENT WAS TREATED WITH MEDICATION. PATIENT IS DOING WELL - NO INJURY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6762721 ↗