Proxis™ Ureteral Access Sheath 231045Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741101694), received between Sep 26, 2019 and Apr 14, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (10 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 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 21832648 ↗
• MalfunctionMar 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGICAL PREPARATION, DISCOVERED THAT THE PROXIES WERE BENT, AND THEY COMPLETED THE PROCEDURE USING A DIFFERENT IDENTICAL PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618378 ↗
• MalfunctionNov 13, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PROXIS ACCESS SHEATH WAS TOO DRY WHEN INSERTING PATIENT'S BODY. THE TAPERED PART OF THE DISTAL TIP OF THE ACCESS SHEATHS WAS NOT SMOOTH. THE EVENT OCCURRED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674532 ↗
• MalfunctionSep 18, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ACCESS SHEATH WAS FOUND TO BE BENT DURING SURGERY PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246116 ↗
• MalfunctionSep 4, 2024Difficult to Insert; Device Contamination with Chemical or Other Material; Difficult to Insert; Device Contamination with Chemical or Other Material

  THERE WERE A LOT OF CASES WHERE THE GUIDEWIRE WOULD NOT GO THROUGH BECAUSE THERE WAS SOMETHING LIKE GLUE REMAINING ON THE CONNECTION BETWEEN THE HUB OF THE DILATOR AND THE GRAY DILATOR. IN MANY CASES, IT WOULD GO THROUGH IF PRESSED IT HARD AND REPEATEDLY, AND MEDICON CLAIMS THAT THIS WAS A DEFECT. LOT #BMJRFM14 AND LOT #UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20137505 ↗
• MalfunctionSep 4, 2024Difficult to Insert; Device Contamination with Chemical or Other Material; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE HAD BEEN MANY CASES WHERE GUIDEWIRE HAD NOT BEEN ABLE TO PASS DUE TO ADHESIVE-LIKE MATERIAL REMAINING BETWEEN THE HUB PART OF THE DILATOR AND THE CONNECTION PART OF THE GRAY DILATOR. IT OFTEN PASSES IF PRESSED IT HARD MANY TIMES, AND MEDICON CLAIM THAT THIS WAS A MEDICAL PROBLEM. THEY WERE ALSO COLLECTING THE ADHESIVE-LIKE MATERIAL THAT CAME OUT. ALTHOUGH THE ITEM SENT THIS TIME HAD BEEN RELEASED, SIMILAR CASES WERE OCCURRING CONTINUOUSLY. LOT#BMJRFM14 AND LOT#UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135887 ↗
• MalfunctionSep 4, 2024Difficult to Insert; Device Contamination with Chemical or Other Material; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE GUIDEWIRE DID NOT PASS THROUGH THE DILATOR BECAUSE THERE WAS A GLUE-LIKE SUBSTANCE REMAINING AT THE CONNECTION BETWEEN THE HUB OF THE DILATOR AND THE GRAY DILATOR, AND THERE HAD BEEN MANY CASES WHERE THE GUIDEWIRE DID NOT PASS THROUGH. IN MANY CASES, IT PASSES THROUGH IF PRESSED IT HARD AND REPEATEDLY, AND IT WAS CLAIMED THAT THIS WAS A DEFECT WITH MEDICON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135717 ↗
• MalfunctionSep 4, 2024Difficult to Insert; Device Contamination with Chemical or Other Material; Difficult to Insert; Device Contamination with Chemical or Other Material

  THERE WERE A LOT OF CASES WHERE THE GUIDEWIRE WOULD NOT GO THROUGH BECAUSE THERE WAS SOMETHING LIKE GLUE REMAINING ON THE CONNECTION BETWEEN THE HUB OF THE DILATOR AND THE GRAY DILATOR. IN MANY CASES, IT WOULD GO THROUGH IF PRESSED IT HARD AND REPEATEDLY, AND MEDICON CLAIMS THAT THIS WAS A DEFECT. LOT#BMJRFM14 AND LOT#UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135649 ↗
• MalfunctionSep 4, 2024Difficult to Insert; Device Contamination with Chemical or Other Material; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE GUIDEWIRE DID NOT PASS THROUGH THE DILATOR. THERE WAS A GLUE-LIKE SUBSTANCE REMAINING AT THE CONNECTION BETWEEN THE HUB OF THE DILATOR AND THE GRAY DILATOR, AND THERE HAD BEEN MANY CASES WHERE THE GUIDEWIRE DID NOT PASS THROUGH. IN MANY CASES, IT PASSES THROUGH IF PRESS IT HARD AND REPEATEDLY, AND IT WAS CLAIMED THAT THIS WAS A DEFECT WITH MEDICON. LOT#BMJRFM14 AND LOT# UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135558 ↗
• MalfunctionSep 4, 2024Difficult to Insert; Device Contamination with Chemical or Other Material; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE GUIDEWIRE DID NOT PASS THROUGH THE DILATOR. THERE WAS A GLUE-LIKE SUBSTANCE REMAINING AT THE CONNECTION BETWEEN THE HUB OF THE DILATOR AND THE GRAY DILATOR, AND THERE HAD BEEN MANY CASES WHERE THE GUIDEWIRE DID NOT PASS THROUGH. IN MANY CASES, IT PASSES THROUGH IF PRESS IT HARD AND REPEATEDLY, AND IT WAS CLAIMED THAT THIS WAS A DEFECT WITH MEDICON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135113 ↗
• MalfunctionSep 3, 2024Difficult to Insert; Device Contamination with Chemical or Other Material; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE HAD BEEN MANY CASES WHERE GUIDEWIRE HAD NOT BEEN ABLE TO PASS DUE TO ADHESIVE-LIKE MATERIAL REMAINING BETWEEN THE HUB PART OF THE DILATOR AND THE CONNECTION PART OF THE GRAY DILATOR. IT OFTEN PASSES IF PRESSED IT HARD MANY TIMES, AND MEDICON CLAIM THAT THIS WAS A MEDICAL PROBLEM. THEY WERE ALSO COLLECTING THE ADHESIVE-LIKE MATERIAL THAT CAME OUT. ALTHOUGH THE ITEM SENT THIS TIME HAD BEEN RELEASED, SIMILAR CASES WERE OCCURRING CONTINUOUSLY. LOT#BMJRFM14 AND LOT#UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128687 ↗
• MalfunctionSep 3, 2024Difficult to Insert; Device Contamination with Chemical or Other Material; Difficult to Insert; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE GUIDEWIRE DID NOT PASS THROUGH THE DILATOR. THERE WAS A GLUE-LIKE SUBSTANCE REMAINING AT THE CONNECTION BETWEEN THE HUB OF THE DILATOR AND THE GRAY DILATOR, AND THERE HAD BEEN MANY CASES WHERE THE GUIDEWIRE DID NOT PASS THROUGH. IN MANY CASES, IT PASSES THROUGH IF PRESS IT HARD AND REPEATEDLY, AND IT WAS CLAIMED THAT THIS WAS A DEFECT WITH MEDICON. LOT#BMJRFM14 AND LOT# UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128424 ↗
• MalfunctionJul 1, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE ACCESS SHEATH MATERIAL DID NOT HAVE THE LUMEN FOR INSERTING A GUIDE WIRE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 28JUN2024, STATED THAT THERE WAS NO PATIENT INVOLVEMENT AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643339 ↗
• MalfunctionJun 21, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE URETERAL ACCESS SHEATH SURFACE OF DILATOR WAS NOT HYDROPHILIC-COATED. IT COULD NOT BE MOVED FORTH AND BACK SMOOTHLY. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 10JUN2024, THE CUSTOMER STATED THAT THE DEFECTIVE PRODUCT DID NOT CAUSE ANY DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585820 ↗
• MalfunctionJun 20, 2024Accessory Incompatible; Difficult to Insert; Accessory Incompatible; Difficult to Insert

  IT WAS REPORTED THAT THE ACCESS SHEATH COULD NOT BE MOVED UP DURING INSERTION. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 06JUN2024, STATED THAT THERE WAS NO PATIENT INVOLVEMENT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 20JUN2024, STATED THAT THEY WERE CONFIRMED THE DEFECT HAPPENED PRIOR TO USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575951 ↗
• MalfunctionDec 13, 2023Partial Blockage; Device Contamination with Body Fluid; Partial Blockage; Device Contamination with Body Fluid

  IT WAS REPORTED THAT URETERAL ACCESS SHEATH WAS BLOCKED DURING STONE SURGERY. SO, THE GUIDE WIRE COULD NOT ENTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318594 ↗
• MalfunctionOct 30, 2023Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT THE GUIDEWIRE DID NOT PASS THROUGH THE SHEATH WHEN THE USER TRIED TO INSERT IT FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18028720 ↗
• MalfunctionMar 8, 2023Flaked; Flaked

  IT WAS REPORTED THAT THE WHILE DOING A CYSTOSCOPY, RIGHT URETEROSCOPY WITH LASER HOLMIUM THE URETERAL ACCESS SHEATH STARTED TO PEEL/SHEAR APART INSIDE THE SHEATH. INCREASED OPERATING ROOM TIME IN ORDER TO WITHDRAW THE FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16503025 ↗
• MalfunctionOct 19, 2022Accessory Incompatible; Partial Blockage; Accessory Incompatible; Partial Blockage

  IT WAS REPORTED THAT THE GUIDEWIRE COULD NOT PASS THROUGH THE ACCESS SHEATH. THE ACCESS SHEATH WAS FOUND TO BE BLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632511 ↗
• MalfunctionFeb 15, 2022Accessory Incompatible; Nonstandard Device; Accessory Incompatible; Nonstandard Device

  IT WAS REPORTED THAT THE FLEXIBLE MIRROR WAS UNABLE TO BE INSERTED INTO THE ACCESS SHEATH. THE USER STATED THAT FOR ANOTHER PRODUCT OF THE SAME SIZE, THERE WAS NO PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534781 ↗
• MalfunctionJun 22, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE SURGEON PROGRESSED THE RIRS (RETROGRADE INTRARENAL SURGERY) PROCEDURE, FOUND OUT THE CRUMPLED PART ON THE END OF SHEATH FOR PROXIS AND ALSO WANTED TO KNOW WHY IT OCCURRED AND MENTIONED THAT PROXIS HAD CAUSED A SEVERE DAMAGE TO THE FLEXIBLE URS SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042425 ↗
• MalfunctionSep 26, 2019Device Damaged by Another Device; Device Contamination with Chemical or Other Material; Device Damaged by Another Device

  IT WAS REPORTED THAT THERE WAS AN UNIDENTIFIABLE THREAD FOUND DURING THE CASE, FROM THE SHEATH. THE DOCTOR HAS INQUIRED ON WHAT THE MATERIAL MAY BE.

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

  MAUDE report 9125858 ↗