Resolute Integrity™ RSINT22526UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169037441), received between Mar 3, 2017 and Jan 9, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 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.

• MalfunctionJan 9, 2018Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID OBTUSE MARGINAL WHICH HAD 99% LESION STENOSIS USING A RESOLUTE INTEGRITY DRUG ELUTING STENT. THE VESSEL DIAMETER WAS 2.5 MM AND THE LESION LENGTH WAS 26 MM. THERE WAS NO DAMAGES NOTED TO PACKAGING, THAT IS, SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING 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 NOT PASS THROUGH PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DID NOT CROSS THE LESION, IT WAS PULLED FROM THE BODY AND INSPECTED. PHYSICIAN THEN DISCOVERED A STENT STRUT PROTRUDING AND CHOSE TO USE A DIFFERENT STENT. THERE WAS NO INJURY TO THE PATIENT OR CLINICAL SEQUELAE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7174415 ↗
• MalfunctionMay 9, 2017Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THAT A RESOLUTE INTEGRITY RX DRUG ELUTING STENT WAS IMPLANTED APPROXIMATELY 7 MONTHS POST ITS EXPIRY DATE. NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. IT WAS REPORTED THAT THE PRODUCT WAS ON CONSIGNMENT AT THE ACCOUNT. THE ACCOUNT HAS A SIGNED CONSIGNMENT AGREEMENT AND ARE RESPONSIBLE FOR CONTROLLING SHORT DATED/EXPIRED PRODUCT. PATIENT REPORTED AS OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6553414 ↗
• MalfunctionMar 3, 2017Burst Container or Vessel; Device Dislodged or Dislocated; Burst Container or Vessel; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT. THE TARGET LESION WAS LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY AND WAS REPORTED TO BE SEVERELY TORTUOUS AND MILDLY CALCIFIED WITH 70-80% STENOSIS. NO DAMAGE TO PACKAGING WAS NOTED AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY WERE RECORDED. THERE WERE NO ISSUES REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. WHEN ADVANCING THE DEVICE, RESISTANCE WAS ENCOUNTERED. MODERATE FORCE WAS USED TO ADVANCE THE DEVICE. THE DEVICE DID NOT REACH THE TARGET LESION. DURING ATTEMPTED STENT DEPLOYMENT, A BALLOON BURST/LEAK/CATHETER LEAK WAS REPORTED. THIS WAS NOTICED FOLLOWING THE FIRST INFLATION. THERE WAS BLOOD IN THE INFLATION DEVICE. IT CANNOT BE CONFIRMED IF THE BALLOON OR CATHETER WAS LEAKING. THE STENT DELIVERY BALLOON COULD ONLY BE INFLATED TO 7 ATM. IT IS REPORTED THAT THE STENT EMBOLISED AND THE PHYSICIAN TRAPPED THE EMBOLIZED STENT WITH TWO OTHER STENTS. NO P

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6375390 ↗