Integrity INT30009UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994798473), received between Mar 9, 2017 and Jun 5, 2019 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionJun 5, 2019Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE A INTEGRITY RX CORONARY BARE METAL STENT WAS USED TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT THE POST OP NURSE DISCOVERED THAT THE DEVICE HAD EXPIRED WHILE REVIEWING THE STENT CARD. THE DEVICE EXPIRED ON THE 11 APRIL 2019 AND WAS USED IN THE PATIENT ON THE (B)(6) 2019. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8669619 ↗
• InjuryApr 9, 2018Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT AN INTEGRITY BARE METAL STENT, WHICH WAS IMPLANTED, RESTENOSED. APPROX 17 MONTHS POST IMPLANT, A SECOND PROCEDURE WAS THEN CARRIED OUT ON BECAUSE THE INTEGRITY STENT RESTENOSED OR "COLLAPSED". A NON-MEDTRONIC STENT WAS IMPLANTED INSIDE OF THE INTEGRITY STENT TO OPEN UP THE STENT.

  Patient problems: Stenosis

  MAUDE report 7406070 ↗
• InjuryMar 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO INTEGRITY STENTS WERE IMPLANTED IN THE RCA AND ONE RESOLUTE ONYX RX DRUG ELUTING STENT IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED NSTEMI. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT REMAINS UNRESOLVED, CONTINUING WITH TREATMENT.

  Patient problems: Myocardial Infarction

  MAUDE report 6390799 ↗