Super Sheath R/O (15-969B) BT90Z11TPWX38Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04543527181839), received between Mar 14, 2025 and Mar 14, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2025Difficult to Insert; Use of Device Problem; Difficult to Insert; Use of Device Problem

  IT WAS REPORTED THAT THE SHEATHS WERE DIFFICULT TO ADVANCE THROUGH THE SKIN RESULTING IN PAIN AND PERINEPHRIC URINOMA WAS TREATED MEDICALLY. TWO 9 FR X 11 CM SUPER SHEATH INTRODUCER SHEATHS OF THE SAME LOT WERE USED DURING THIS ANTEGRADE URETERIC STENTING OF THE RIGHT KIDNEY. IT WAS REPORTED THAT THE SHEATHS WERE DIFFICULT TO ADVANCE THROUGH THE SKIN TO THE RIGHT KIDNEY CAUSING A LOT OF PAIN TO THE RIGHT SIDE OF THE BACK ACCESS POINT. THE RADIOLOGIST DILATED UP TO A 10 FR DILATOR (USING DILATORS - 6,7,8,9,10) TO AID DILATION OF THE TRACK FOR THE 9 FR SHEATH PLACEMENT WITH DIFFICULTY. THE STENT WAS SUCCESSFULLY PLACED. AS A RESULT OF THE PAIN, THE PATIENT WAS TREATED IMMEDIATELY POST-PROCEDURE WITH PARACETAMOL, IBUPROFEN AND IV FENTANYL. THE PATIENT HAD PROGRESSIVE WORSENING PAIN, AND A CT SCAN REVEALED AN EXTRAVASATION OF CONTRAST IN KEEPING WITH A PERINEPHRIC URINOMA WHICH MAY HAVE BEEN CONTRIBUTED TO BY THE SHEATH OR THE ASSOCIATED DILATATION REQUIRED TO INSERT IT. THE PATIENT WAS REFERRED TO UROLOGY FOR INPATIENT ADMISSION FOR ONGOING OBSERVATION AND PAIN MANAGEMENT, IV FLUIDS. THE PATIENT HAD SOME URINARY RETENTION RELATED TO THEIR BLADDER OUTFLOW OBSTRUCTION THAT RESULTED IN W

  Patient problems: Extravasation; Pain

  MAUDE report 21607201 ↗
• InjuryMar 14, 2025Difficult to Insert; Use of Device Problem; Difficult to Insert; Use of Device Problem

  IT WAS REPORTED THAT THE SHEATHS WERE DIFFICULT TO ADVANCE THROUGH THE SKIN RESULTING IN PAIN AND PERINEPHRIC URINOMA WAS TREATED MEDICALLY. TWO 9 FR X 11 CM SUPER SHEATH INTRODUCER SHEATHS OF THE SAME LOT WERE USED DURING THIS ANTEGRADE URETERIC STENTING OF THE RIGHT KIDNEY. IT WAS REPORTED THAT THE SHEATHS WERE DIFFICULT TO ADVANCE THROUGH THE SKIN TO THE RIGHT KIDNEY CAUSING A LOT OF PAIN TO THE RIGHT SIDE OF THE BACK ACCESS POINT. THE RADIOLOGIST DILATED UP TO A 10 FR DILATOR (USING DILATORS - 6,7,8,9,10) TO AID DILATION OF THE TRACK FOR THE 9 FR SHEATH PLACEMENT WITH DIFFICULTY. THE STENT WAS SUCCESSFULLY PLACED. AS A RESULT OF THE PAIN, THE PATIENT WAS TREATED IMMEDIATELY POST-PROCEDURE WITH PARACETAMOL, IBUPROFEN AND IV FENTANYL. THE PATIENT HAD PROGRESSIVE WORSENING PAIN, AND A CT SCAN REVEALED AN EXTRAVASATION OF CONTRAST IN KEEPING WITH A PERINEPHRIC URINOMA WHICH MAY HAVE BEEN CONTRIBUTED TO BY THE SHEATH OR THE ASSOCIATED DILATATION REQUIRED TO INSERT IT. THE PATIENT WAS REFERRED TO UROLOGY FOR INPATIENT ADMISSION FOR ONGOING OBSERVATION AND PAIN MANAGEMENT, IV FLUIDS. THE PATIENT HAD SOME URINARY RETENTION RELATED TO THEIR BLADDER OUTFLOW OBSTRUCTION THAT RESULTED IN W

  Patient problems: Extravasation; Pain

  MAUDE report 21607191 ↗