Proxis Ureteral Access SheathRecalls & reported problems across all models
C. R. Bard, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 81
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 9 models of Proxis Ureteral Access Sheath by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between May 2, 2017 and Sep 18, 2026 — classified as 5 injuries, 76 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Proxis Ureteral Access Sheath problems
Device problems
- Device Contamination with Chemical or Other Material20
- Difficult to Insert19
- Accessory Incompatible8
- Flaked7
- Misassembled7
- Partial Blockage7
- Material Twisted/Bent6
- Material Fragmentation5
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- No Known Impact Or Consequence To Patient20
- No Consequences Or Impact To Patient17
- Foreign Body In Patient4
- Injury2
- No Patient Involvement2
- Device Embedded In Tissue or Plaque1
- Discomfort1
Proxis Ureteral Access Sheath models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Proxis™ Ureteral Access Sheath 231045endoscopic access overtube, gastroenterology-urology22 reports
- Proxis™ Ureteral Access Sheath 231035endoscopic access overtube, gastroenterology-urology20 reports
- Proxis™ Ureteral Access Sheath 231235endoscopic access overtube, gastroenterology-urology11 reports
- Proxis™ Ureteral Access Sheath 231225endoscopic access overtube, gastroenterology-urology9 reports
- Proxis™ Ureteral Access Sheath 231245endoscopic access overtube, gastroenterology-urology9 reports
- Proxis™ Ureteral Access Sheath 231025endoscopic access overtube, gastroenterology-urology6 reports
- Proxis Ureteral Access Sheath 231125endoscopic access overtube, gastroenterology-urology2 reports
- Proxis Ureteral Access Sheath 231135endoscopic access overtube, gastroenterology-urology1 report
- Proxis Ureteral Access Sheath 231145endoscopic access overtube, gastroenterology-urology1 report
Recent Proxis Ureteral Access Sheath adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Material Too Rigid or Stiff
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828913 ↗MalfunctionMar 21, 2026Flaked; Material Separation
IT WAS REPORTED THAT AFTER REMOVING THE DILATOR, THE SHEATH WAS PEELING LIKE A SPLINTER ON THE INSIDE OF THE SHEATH TIP, END POINT. PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 19MAR2026, STATED THAT RATHER THAN COMPLETE DETACHMENT, IT APPEARS TO BE A FRAYING OR SPLITTING CONDITION, THOUGH THE EXACT NATURE WAS UNCLEAR AND ITS USE WAS DISCONTINUED IMMEDIATELY UPON NOTICING THE ISSUE, SO THERE WERE NO RESIDUAL FRAGMENTS LEFT IN THE BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24656979 ↗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 ↗MalfunctionNov 24, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH ITEM # 231225 DURING SURGERY. THE ACCESS SHEATH BROKE IN HALF, AND THE SURGEON HAD TO RETRIEVE THE OF SHEATH. PER CUSTOMER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 21JAN2026, IT WAS REPORTED THAT THE PRODUCT WAS NO LONGER AVAILABLE TO BE RETURNED. THERE WAS NO PATIENT IMPACT, AND THE BROKEN ITEM WAS REMOVED IN ENTIRETY BY THE DOCTOR.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23632789 ↗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 ↗MalfunctionJul 2, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE URETERAL ACCESS SHEATH HANDLE PART WAS BROKEN AND CANNOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22383944 ↗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, 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 ↗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 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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