Integrity INT30030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994798534), received between May 24, 2017 and Apr 4, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 4, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN INTEGRITY BARE METAL STENT BENT WHILE ATTEMPTING TO CROSS A LESION IN THE MID RCA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7395076 ↗
• MalfunctionNov 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE AN INTEGRITY RX CORONARY BARE METAL STENT TO TREAT A NON-CALCIFIED AND NON-TORTUOUS LESION. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUED IDENTIFIED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE CATHETER FRACTURED DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. IT WAS DESCRIBED THAT THE STENT CATHETER WOULD NOT ADVANCE THROUGH THE SHEATH SO THE DEVICE WAS PULLED BACK OUT. THE DEVICE NEVER ENTERED THE PATIENT'S VESSEL, THE DEVICE REMAINED IN THE GUIDE CATHETER AND NO COMPONENTS REMAINED IN THE PATIENT. ANOTHER DEVICE WAS ADVANCED WITH NO ISSUE TO COMPLETE THE PROCEDURE. PATIENT STATUS POST PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7066207 ↗
• MalfunctionMay 24, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A INTEGRITY BARE-METAL STENT TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY, CIRCUMFLEX (CX) ARTERY AND THE OBTUSE MARGINAL (OM). THE LESION WAS REPORTED TO BE SEVERELY TORTUOUS AND SEVERELY CALCIFIED WITH (B)(4) STENOSIS. IT WAS REPORTED THAT THERE WAS A SHARP 90 DEGREE BEND FROM LEFT MAIN INTO THE CIRCUMFLEX. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM PACKAGING. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS ALSO PERFORMED WITH NO ISSUES. THE 3.0 X 30 INTEGRITY WAS ATTEMPTED FIRST. THE LESION WAS NOT PRE-DILATED AND THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT BUT RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT WAS REPORTED THAT THE STENT DID NOT CROSS THE LESION AND AFTER IT WAS REMOVED FROM THE BODY A STENT STRUT ON THE PROXIMAL END WAS NOTED TO BE BENT OUT. A 3.0 X 18 INTEGRITY WAS THEN USED IN CASE A SHORTER STENT WOULD BE ABLE TO CROSS. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT BUT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6586899 ↗