Proxis™ Ureteral Access Sheath 231035Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741101687), received between May 26, 2017 and Feb 4, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Difficult to Insert

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO INSERT THE GUIDEWIRE, BUT IT WAS DIFFICULT TO INSERT IT. REPLACED WITH NEW SAME MODEL TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259541 ↗
• MalfunctionDec 29, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE GUIDEWIRE INSERTION FAILED DUE TO DISTAL TIP OCCLUSION AND RESISTANCE IN URETERAL ACCESS SHEATH. REPLACED WITH A NEW PROXIS(SAME MODEL) AND COMPLETED THE PROCEDURE WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915503 ↗
• MalfunctionDec 10, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT, THE BASKET COULD NOT BE ADVANCED INTO THE PROXIS URETERAL SHEATH. AFTER MULTIPLE FAILED ATTEMPTS, THE PROCEDURE WAS FINALIZED USING A NEW, IDENTICAL PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772618 ↗
• MalfunctionAug 22, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT THERE WAS RESISTANCE IN THE ACCESS SHEATH, AND THE GUIDEWIRE CANNOT PASS THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874249 ↗
• MalfunctionJul 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE URETERAL SHEATH HAD POOR SHAPE SO THE GUIDEWIRE DID NOT PASS THROUGH THE DILATOR SO THE FLEXIBLE PART COULD NOT BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458550 ↗
• MalfunctionApr 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING USE, WHEN USING URF-V3, THE ENDOSCOPE GOT CAUGHT IN THE SHEATH LUMEN AND COULD NOT BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868597 ↗
• MalfunctionApr 15, 2025Nonstandard Device; Device Contamination with Chemical or Other Material; Nonstandard Device; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BEFORE USE, ACCESS SHEATH COULD NOT BE USED DUE TO FOREIGN SUBSTANCES FOUND IN THE MIDDLE PART. LOT#BMJRFM31, LOT#BMJQFM25. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 09APR2025, STATED THAT THERE WERE TWO DEFECTIVE PRODUCTS WERE FOUND IN LOT#BMJRFM31 AND LOT#BMJQFM25.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21840851 ↗
• MalfunctionApr 14, 2025Partial Blockage; Difficult to Insert; Device Contamination with Chemical or Other Material; Partial Blockage; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PHENOMENON HAD OCCURRED WHERE THE GLUE INSIDE THE DILATOR WAS CLOGGED AND PREVENTED THE GUIDEWIRE FROM PASSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832607 ↗
• MalfunctionApr 14, 2025Partial Blockage; Difficult to Insert; Device Contamination with Chemical or Other Material; Partial Blockage; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ADHESIVE WAS STUCK IN THE DILATOR OF THE ACCESS SHEATH AND GUIDEWIRE COULD NOT PASS THROUGH. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 28MAR2025, CUSTOMER CONFIRMED THAT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832603 ↗
• MalfunctionApr 14, 2025Partial Blockage; Difficult to Insert; Device Contamination with Chemical or Other Material; Partial Blockage; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE GUIDEWIRE CANNOT PASS THROUGH THE DILATER. A SITUATION HAS OCCURRED WHERE ADHESIVE WAS CLOGGED INSIDE THE DILATER, PREVENTED GUIDEWIRE FROM PASSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832572 ↗
• MalfunctionApr 14, 2025Partial Blockage; Difficult to Insert; Device Contamination with Chemical or Other Material; Partial Blockage; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ADHESIVE WAS STUCK IN THE DILATOR OF THE ACCESS SHEATH AND GUIDEWIRE COULD NOT PASS THROUGH. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 28MAR2025, CUSTOMER CONFIRMED THAT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832536 ↗
• MalfunctionNov 25, 2024

  UNABLE TO PASS GUIDEWIRE THROUGH LUER LOCK HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771005 ↗
• MalfunctionJun 17, 2024Nonstandard Device; Device Contamination with Chemical or Other Material; Nonstandard Device; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING USE, THERE WAS FOREIGN MATTER LIKE RESIN PIECES THAT WERE MIXED IN THE DILATOR CATHETER. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 13JUN2024, CONFIRMED THAT THE RESIN PIECE WAS PRESENT INSIDE THE DILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547055 ↗
• MalfunctionMay 24, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE LUMEN OF THE INNER TUBE WAS BLOCKED, AND THE GUIDE WIRE CANNOT PASS THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390749 ↗
• MalfunctionJan 2, 2024Accessory Incompatible; Material Protrusion/Extrusion; Accessory Incompatible; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A FLEXIBLE URETEROSCOPE COULD NOT BE PLACED IN THE URETERAL ACCESS SHEATH. PER CUSTOMER FOLLOW UP RECEIVED ON 02FEB2024, IT WAS REPORTED THAT WHEN HOSPITAL USED THIS MODEL OF URETERAL SHEATH, THE DILATOR WAS REMOVED AND THE ENDOSCOPE WAS FOUND TO BE UNABLE TO ENTER THE EXTERNAL SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427763 ↗
• MalfunctionAug 4, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE SURFACE OF URETERAL ACCESS SHEATH WAS NOT SMOOTH BUT STIFF WHEN OPENING THE PACKAGE OF PROXIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466798 ↗
• MalfunctionMay 19, 2023Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PIECE OF PLASTIC WAS FOUND INSIDE THE DILATOR OF THE URETERAL ACCESS SHEATH BEFORE USE. A PIECE OF PLASTIC WAS PUSHED OUT FROM THE DILATOR ON THE HUB SIDE BY THE GUIDEWIRE WHEN THE GUIDEWIRE WAS INSERTED FROM THE DISTAL TIP BEFORE USE ON THE PATIENT. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 12MAY2023, STATED THAT THIS PLASTIC PIECE WAS A FOREIGN MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961237 ↗
• MalfunctionDec 12, 2019Flaked; Flaked; Peeled/Delaminated

  IT WAS REPORTED THAT THE COATING ON THE ACCESS SHEATH PEELED OFF DURING THE PROCEDURE. ALL FRAGMENTS OF THE PEELING WAS COLLECTED, AND NO PIECES REMAINED IN THE PATIENT'S BODY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9459916 ↗
• InjuryAug 7, 2018Patient-Device Incompatibility; Compatibility Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT ALLEGEDLY EXPERIENCED SEPSIS AFTER A RIRS (RETROGRADE INTRARENAL SURGERY) WAS DONE WITH A 10/12FR PROXIS AND LITHOVUE. THE FACILITY PERFORMED A REVIEW TO ANALYZE THE EVENT. THE ANALYSIS CONCLUDED THAT THE PATIENT PROFILE, STONE SIZE, AND LOCATION WERE ALL SIMILAR TO OTHER PATIENTS DR. (B)(6) HAS, AND ALL THE DEVICES USED ARE THE SAME EXCEPT FOR THE SIZE OF THE ACCESS SHEATH. THE DEPARTMENT CONCLUDED THAT THE ROOT OF THE PROBLEM WAS THE ACCESS SHEATH SIZE. DR. (B)(6) STATED THAT THE EVENT MAY HAVE BEEN CAUSED BY BAD OUTFLOW OF IRRIGATION, WHICH LED TO REFLUX, AND CAUSED INFECTION TO GET INTO THE BLOODSTREAM. IT WAS LATER REPORTED ON 07/24/2018 THAT THE DOCTOR NORMALLY USED SIZE 12/14 FR. HE STATED THAT HE SELECTED SIZE 10/12 FR. BECAUSE SOMETIMES THE 12/14 FR. SIZE WAS TOO BIG FOR SOME OF THE (B)(6) POPULATION. THE ACCESS SHEATH WAS NOT TOO SMALL FOR THE STONE SIZE. IT WAS TOO TIGHT TO WORK WITH A 9+ FR. SCOPE. THE STONE SIZE WAS NOT GIVEN.

  Patient problems: Sepsis

  MAUDE report 7756193 ↗
• MalfunctionMay 26, 2017Device Damaged by Another Device

  IT WAS REPORTED THAT THE URETERAL ACCESS SHEATH SHAVED OFF PART OF THE SCOPE CASING. THERE WERE ALLEGEDLY NO PIECES REMAINING IN THE PATIENTS BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6595339 ↗