Bard® InLay® Versa Fit® Ureteral Stent 778600Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741014789), received between Dec 6, 2017 and Apr 16, 2024 — classified as 13 injuries, 9 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, 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 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 ↗
• 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 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 ↗
• InjuryOct 28, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED OCCLUSION, URINARY SYMPTOMS, PAIN AND DISCOMFORT WHILE USING THE BARD URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY SYMPTOMS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain

  MAUDE report 12711596 ↗
• InjuryOct 25, 2021Calcified; Biocompatibility; Calcified; Biocompatibility

  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 OF COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Calcium Deposits/Calcification

  MAUDE report 12693900 ↗
• InjuryOct 25, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  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 OR BLADDER, URETERAL EROSION, INFECTION, URINARY SYMPTOMS WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12693743 ↗
• InjuryOct 25, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  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 OR BLADDER, URETERAL EROSION , INFECTION , URINARY SYMPTOMS WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12693646 ↗
• InjuryOct 25, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USER MENTIONED THE FOLLOWING COMPLICATIONS: 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 WHILE USING THE URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain

  MAUDE report 12693643 ↗
• MalfunctionOct 22, 2021Calcified; Calcified

  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 OR BLADDER, URETERAL EROSION , INFECTION , URINARY SYMPTOMS WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681651 ↗
• MalfunctionOct 22, 2021Partial Blockage; Partial Blockage

  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 OR BLADDER, URETERAL EROSION , INFECTION , URINARY SYMPTOMS WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681559 ↗
• InjuryOct 22, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  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 OR BLADDER, URETERAL EROSION , INFECTION , URINARY SYMPTOMS WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Internal Organ Perforation

  MAUDE report 12681554 ↗
• InjuryOct 22, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  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 OR BLADDER, URETERAL EROSION , INFECTION , URINARY SYMPTOMS WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Erosion

  MAUDE report 12681553 ↗
• MalfunctionOct 22, 2021Migration; Migration

  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 OR BLADDER, URETERAL EROSION , INFECTION , URINARY SYMPTOMS WHEN ASKED OF COMPLICATIONS WHILE USING THE URETERAL STENT. NO MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681552 ↗
• InjuryOct 21, 2021Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USER MENTIONED THE FOLLOWING COMPLICATIONS INCLUDING 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 WHILE USING THE URETERAL STENT. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Extravasation

  MAUDE report 12674202 ↗
• InjuryDec 6, 2017Knotted

  IT WAS REPORTED THAT A KNOT DEVELOPED AT THE PROXIMAL END OF THE DEVICE MAKING IT DIFFICULT TO REMOVE; CAUSING THE PROCEDURE TO BE PROLONGED FOR 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7087474 ↗