Express® SD Renal/Biliary H74937912618900Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729484851), received between Jan 18, 2019 and Mar 17, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 6.0MM X 18MM X 90CM EXPRESS SD RENAL/BILIARY WAS SELECTED FOR USE. UPON OPENING THE PACKAGE, IT WAS NOTED THAT THE STENT WAS BROKEN INSIDE THE PACKAGING. ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620084 ↗
• InjuryNov 19, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT FRACTURED, REQUIRING SURGERY FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MESENTERIC ARTERY. A 6.0MMX18MMX90CM EXPRESS SD RENAL/BILIARY STENT BALLOON EXPANDABLE WAS ADVANCED FOR BALLOON ANGIOPLASTY AND STENT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN USED AN 6F X 45CM ANGLED NON-BOSTON SCIENTIFIC (BSC) INTRODUCER SHEATH AS A PROTECTION IN THE RIGHT COMMON FEMORAL ARTERY TO EXPOSE THE STENT. UPON DOING SO, THE STENT BALLOON PULLED BACK. WHEN ADVANCING FORWARD, THE STENT ABRUPTLY RELEASED FROM THE BALLOON SHAFT. THE STENT REMAINED UNDEPLOYED OVER THE NON-BSC WIRE DISTALLY. THE PHYSICIAN DEPLOYED A SINGLE LOOP SNARE TO REMOVE THE DISTAL END OF THE WIRE AND STENT. THEN, ATTEMPTED TO REMOVE THE STENT THROUGH THE 6F NON-BSC SHEATH BUT WITHOUT SUCCESS. THE PHYSICIAN THEN INSERTED AN 8F X 45CM NON-BSC SHEATH IN THE LEFT COMMON FEMORAL ARTERY TO APPROACH FROM THE OTHER SIDE AND REMOVE IT THROUGH A LARGER SHEATH. A THREE-LOOP SNARE FROM THE LEFT COMMON FEMORAL ARTERY WAS INSERTED AND THEN SNARED THE STENT, BUT THEN AGAIN IT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO USE AN 8X39CM NON-BSC STENT TO COVER THE E

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20729709 ↗
• MalfunctionMar 9, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED RENAL ARTERY. A 6.0MMX18MMX90CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. THE STENT BALLOON WAS INFLATED AT 8 ATMOSPHERES FOR 10 SECONDS. THE STENT WAS DEPLOYED AND THE STENT BALLOON WAS THEN FULLY DEFLATED PRIOR TO REMOVAL. HOWEVER, DURING REMOVAL, RESISTANCE WAS ENCOUNTERED AS THE BALLOON WOULD COME OUT OF THE SHEATH. THE SHEATH HAD TO BE REMOVED AND THE WIRE PLACE WAS LOST. A NEW SHEATH HAD TO BE REINSERTED WHICH COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16517748 ↗
• InjuryJan 21, 2021Failure to Advance; Device Dislodged or Dislocated; Migration; Failure to Advance; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 6.0MMX18MMX90CM EXPRESS SD STENT WAS ADVANCED FOR TREATMENT BUT HAD DIFFICULTY IN GOING THROUGH THE LESION. THE PHYSICIAN HAD TO RETRIEVE THE CATHETER; HOWEVER, THE STENT DETACHED AND MIGRATED TO ANOTHER RENAL ARTERY. THE STENT WAS SNARED AND WAS REMOVED BY THE INTRODUCER IN PLACE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11206839 ↗
• InjuryMar 6, 2020Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERIOR MESENTERIC ARTERY. A 6.0MMX18MMX90CM EXPRESS SD STENT WAS DEPLOYED FAR INTO THE AORTA. SUBSEQUENTLY, ANOTHER 6.0MMX18MMX90CM EXPRESS SD STENT WAS ADVANCED TO ANCHOR WITH THE ALREADY DEPLOYED STENT. HOWEVER, THE STENT CAME OFF THE BALLOON AS WELL AS KNOCKING THE ALREADY DEPLOYED STENT OUT OF PLACE. BOTH STENTS WERE SNARED AND RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799873 ↗
• InjuryMar 6, 2020Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERIOR MESENTERIC ARTERY. A 6.0MMX18MMX90CM EXPRESS SD STENT WAS DEPLOYED FAR INTO THE AORTA. SUBSEQUENTLY, ANOTHER 6.0MMX18MMX90CM EXPRESS SD STENT WAS ADVANCED TO ANCHOR WITH THE ALREADY DEPLOYED STENT. HOWEVER, THE STENT CAME OFF THE BALLOON AS WELL AS KNOCKING THE ALREADY DEPLOYED STENT OUT OF PLACE. BOTH STENTS WERE SNARED AND RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799723 ↗
• InjuryAug 22, 2019Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT STENT FRACTURE AND STENT MIGRATION OCCURRED. IN THE END OF (B)(6) 2019, A 6.0 MM X 18 MM X 90 CM EXPRESS SD STENT WAS IMPLANTED IN THE LEFT RENAL ARTERY IN AN UNSPECIFIED HOSPITAL AND BY AN UNSPECIFIED PHYSICIAN. ON (B)(6) 2019, IMAGING, AT A DIFFERENT HOSPITAL THAN WHERE THE STENT WAS IMPLANTED, IDENTIFIED THAT THE STENT WAS IN A LESS THAN IDEAL SPOT (MOSTLY HANGING INTO THE AORTA) AND FRACTURED. THE PHYSICIAN THAT FOUND THIS ISSUE DID NOT PERFORM ANY INTERVENTIONS WHEN THIS ISSUE WAS NOTED AS THE PATIENT AND THEIR FAMILY WISHED TO SEEK TREATMENT AND OTHER MEDICAL OPINIONS ELSEWHERE. THEY DID NOT CONSENT TO TREAT AS THEY WERE WORRIED ABOUT THE RISK OF MIGRATION AND FURTHER COMPLICATIONS THAT COULD OCCUR WITH AN ATTEMPT TO REMOVE THE STENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 8920163 ↗
• MalfunctionJan 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 6.0MMX18MMX90CM EXPRESS SD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8260603 ↗