Integrity INT25026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994798800), received between Apr 7, 2020 and Feb 17, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2021Device Dislodged or Dislocated

  DURING A PROCEDURE, IT WAS INTENDED TO USE ONE INTEGRITY RX CORONARY STENT SYSTEM TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THERE WAS NO ISSUES NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. IT WAS REPORTED THAT THE STENT WAS NOTED TO BE MISSING FROM THE BALLOON CATHETER. IT WAS STATED THAT THE DEVICE WAS NOT USED IN THE PATIENT. IT WAS LATER CONFIRMED THAT THE BALLOON WAS INSERTED INTO THE LAD AND INFLATED. IT WAS NOT REALIZED THAT THERE WASN'T A STENT ON THE BALLOON. IT WAS STATED THAT A VERIFICATION CHECK WAS CONDUCTED VIA IVUS THAT THERE WAS NOT A STENT INSIDE THE PATIENT POST DEFLATION OF THE BALLOON. THE GUIDE CATHETER WAS ALSO CHECKED AFTER THE PROCEDURE TO VERIFY THAT THE STENT WAS NOT IN THE GUIDE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339718 ↗
• InjuryMay 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE INTEGRITY RX CORONARY STENT SYSTEM TO TREAT A LESION LOCATED IN THE MID CIRCUMFLEX ARTERY. IT WAS REPORTED THAT A NON-MEDTRONIC GUIDE WIRE CROSSED THE LESION, HOWEVER THE STENT FAILED TO CROSS THE LESION AND STENT DISLODGEMENT OCCURRED ON REMOVAL OF THE DEVICE FROM THE PATIENT. FLUOROSCOPY EXAMINATION SHOWED THE STENT DISLODGED IN THE COMMON FEMORAL ARTERY AREA CLOSE TO THE TIP OF THE FEMORAL SHEATH. THE STENT BECAME EMBOLIZED DOWNSTREAM OF THE FEMORAL ARTERY SYSTEM. IT WAS STATED THAT THE STENT IS LODGED IN THE DISTAL TIBIOPERONEAL TRUNK AND MOSTLY IN THE PERONEAL ARTERY AND EVIDENCE OF FLOW THROUGH ALL OUTFLOW VESSELS WAS OBSERVED. IT WAS STATED THAT THE PATIENT IS ASYMPTOMATIC. THERE IS NO EVIDENCE OF LIMB ISCHEMIA. IT WAS STATED THAT ATTEMPTS TO RETRIEVE THE DEVICE WOULD POTENTIALLY CAUSE MORE HARM WITH POSSIBLE VASCULAR INJURY. THE PATIENT WILL NEED LONG TERM SURVEILLANCE OF THE RIGHT LOWER EXTREMITY VESSELS.

  Patient problems: Injury

  MAUDE report 10078716 ↗
• MalfunctionApr 7, 2020Component Missing; Component Missing

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO INTEGRITY RX CORONARY STENT SYSTEMS TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION EXHIBITING 95% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICES PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP. THE DEVICES WERE NOT INSPECTED BEFORE USE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED PRIOR TO USING THE STENT WITH LOT NUMBER 0009829389. THE LESION WAS NOT PRE-DILATED PRIOR TO USING THE STENT WITH LOT NUMBER 0009900545. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENTS MAY NOT HAVE BEEN ON THE CATHETER PRIOR TO USE. IT WAS STATED THAT THERE IS NO EVIDENCE OF THE STENTS IN THE VESSEL POST BALLOON INFLATION. IT WAS NOTED THAT SEVERAL OTHER INTEGRITY STENTS WERE PLACED AFTER THE FIRST TWO STENTS WERE ALLEGEDLY DEPLOYED AND THESE STENTS ARE VISIBLE IN THE VESSEL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933138 ↗
• MalfunctionApr 7, 2020Component Missing; Component Missing

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO INTEGRITY RX CORONARY STENT SYSTEMS TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION EXHIBITING 95% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICES PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP. THE DEVICES WERE NOT INSPECTED BEFORE USE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED PRIOR TO USING THE STENT WITH LOT NUMBER 0009829389. THE LESION WAS NOT PRE-DILATED PRIOR TO USING THE STENT WITH LOT NUMBER 0009900545. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENTS MAY NOT HAVE BEEN ON THE CATHETER PRIOR TO USE. IT WAS STATED THAT THERE IS NO EVIDENCE OF THE STENTS IN THE VESSEL POST BALLOON INFLATION. IT WAS NOTED THAT SEVERAL OTHER INTEGRITY STENTS WERE PLACED AFTER THE FIRST TWO STENTS WERE ALLEGEDLY DEPLOYED AND THESE STENTS ARE VISIBLE IN THE VESSEL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933109 ↗