Bard InLay Versa Fit Ureteral StentRecalls & reported problems across all models
C. R. Bard, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 0
We found 4 models of Bard InLay Versa Fit Ureteral Stent by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2017 and Apr 8, 2026 — classified as 13 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (9 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 Bard InLay Versa Fit Ureteral Stent problems
Device problems
- Patient Device Interaction Problem9
- Biocompatibility8
- Calcified5
- Complete Blockage3
- Device Dislodged or Dislocated2
- Migration2
- Partial Blockage2
- Positioning Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Discomfort3
- No Known Impact Or Consequence To Patient3
- Pain3
- Calcium Deposits/Calcification1
- Erosion1
- Extravasation1
Bard InLay Versa Fit Ureteral Stent models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® InLay® Versa Fit® Ureteral Stent 778600STENT, URETERAL22 reports
- Bard® InLay® Versa Fit® Ureteral Stent 778400STENT, URETERAL3 reports
- Bard® InLay® Versa Fit® Ureteral Stent 778700STENT, URETERAL3 reports
- Bard® InLay® Versa Fit® Ureteral Stent 778800STENT, URETERAL1 report
Recent Bard InLay Versa Fit Ureteral Stent adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2026Complete Blockage
CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY STATED THAT IN CHARTS 5 AND 6, IN THE ONLINE SURVEY A DR., IN QUESTION: "WAS THE STENT SUCCESSFUL IN RELIEVING URETERAL OBSTRUCTION TO ALLOW FOR URINE " SHE/HE ANSWERED "NO¿ BECAUSE "OBSTRUCTION" IN BOTH CHARTS. THE CODE OF PRODUCT ARE THE FOLLOWING: CHART 5-778700, CHART 6- 778800.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821861 ↗MalfunctionApr 7, 2026Complete Blockage
CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY STATED THAT IN CHARTS 5 AND 6, IN THE ONLINE SURVEY A DR., IN QUESTION: "WAS THE STENT SUCCESSFUL IN RELIEVING URETERAL OBSTRUCTION TO ALLOW FOR URINE " SHE/HE ANSWERED "NO¿ BECAUSE "OBSTRUCTION" IN BOTH CHARTS. THE CODE OF PRODUCT ARE THE FOLLOWING: CHART 5-778700 , CHART 6- 77880.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810861 ↗MalfunctionApr 16, 2024Calcified; Calcified
CRITICAL CARE NURSES REPORTED IN A PMCF A PHYSICIAN STATED THAT THEIR PATIENT EXPERIENCED STENT ENCRUSTATION AFTER PLACEMENT OF THE DEVICE. THE RESPONDENT INDICATED THEY BELIEVED THE COMPLICATION TO BE A PROCEDURE RELATED OTHER AND INDICATED THE COMPLICATION TO BE ATTRIBUTED TO UNSURE COULD BE METABOLIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19117148 ↗InjuryMar 27, 2024Migration; Migration
IT WAS REPORTED THAT THE PATIENT REQUIRED NEPHROSTOMY TUBE EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE 778600 - INLAY VERSAFITTM MULTI-LENGTH URETERAL STENT WITHOUT GUIDEWIRE, 6FR., 22CM32CM AND THE PATIENT EXPERIENCED STENT MIGRATION, OCCLUSION. THIS DID RESULTED IN THE PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18985524 ↗InjuryMar 26, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE PATIENT REQUIRED NEPHROSTOMY TUBE EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE 778600 - INLAY VERSAFITTM MULTI-LENGTH URETERAL STENT WITHOUT GUIDEWIRE, 6FR., 22CM32CM AND THE PATIENT EXPERIENCED STENT MIGRATION, OCCLUSION. THIS DID RESULTED IN THE PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18978345 ↗InjuryMar 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT FOR STENT REMOVAL AND EXCHANGE EXPERIENCED AN ADVERSE EVENT DIRECTLY ATTRIBUTABLE TO THE DEVICE 778600 - INLAY VERSAFITTM MULTI-LENGTH URETERAL STENT WITHOUT GUIDEWIRE, 6FR., 22CM32CM AND THE PATIENT EXPERIENCED PAIN, DISCOMFORT. THIS DID RESULTED IN THE PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION.
Patient problems: Discomfort; Pain
MAUDE report 18978326 ↗MalfunctionJan 18, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT CUSTOMER HAD A DEFECTIVE STENT DURING SURGERY. THE PUSHER (ORANGE) WAS LARGER IN LUMEN SIZE AND THE STENT, SO IT WAS SLIDING OVER THE STENT NOT PUSHING IT UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18535032 ↗MalfunctionJun 12, 2023Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY WERE NOT ABLE TO RELIEVE URETERAL OBSTRUCTION TO ALLOW FOR URINE DRAINAGE BECAUSE DIFFICULT TO ACCESS IN RELATION TO INLAY VERSAFIT MULTI-LENGTH URETERAL STENT WITHOUT GUIDEWIRE, 6FR 22CM32CM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17105823 ↗InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURKHOLDERIA BACTERIMIA SECONDATY TO URINARY STENTS, POSSIBLY FROM STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14272643 ↗MalfunctionNov 22, 2021Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE PATIENT EXPERIENCED OCCLUSION, STENT ENCRUSTATION, PAIN, DISCOMFORT AND URINARY SYMPTOMS BY USING THE URETERAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12851782 ↗MalfunctionNov 19, 2021Calcified; Calcified
IT WAS REPORTED THAT THE PATIENT EXPERIENCED OCCLUSION, STENT ENCRUSTATION, PAIN, DISCOMFORT AND URINARY SYMPTOMS WHILE USING THE URETERAL STENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 12843528 ↗MalfunctionNov 9, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT THE URETERAL STENT WITH CATHETER EXHIBITED FAILURE DURING POSITIONING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12781110 ↗MalfunctionNov 4, 2021Calcified; Calcified
IT WAS REPORTED THAT THE PATIENT EXPERIENCED STONE FORMATION, PAIN AND DISCOMFORT WHILE USING THE URETERAL STENTS. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751227 ↗MalfunctionOct 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE RESPONDENT MENTIONED STONE FORMATION, EXTRAVASATION, URETERAL REFLUX, STENT DISLODGEMENT AND MIGRATION, OCCLUSION, PAIN/DISCOMFORT, STENT ENCRUSTATION, PERFORATION OF KIDNEY, RENAL PELVIS, URETER AND/OR BLADDER, URETERAL EROSION, INFECTION, URINARY SYMPTOMS WHEN ASKED ABOUT COMPLICATIONS WHILE USING THE URETERAL STENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12719662 ↗MalfunctionOct 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE USER MENTIONED THE FOLLOWING COMPLICATIONS: EDEMA, URETERAL REFLUX, STENT DISLODGEMENT AND MIGRATION, PAIN AND DISCOMFORT, STENT ENCRUSTATION AND HYDRONEPHROSIS WHILE USING THE URETERAL STENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12719253 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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