Bard® InLay Optima® Ureteral Stent 788422Recalls & reported problems
C. R. Bard, Inc. · INLAY OPTIMA URETERAL STENT W/O GUIDEWIRE · Class 2 · Implant
All models of Bard InLay Optima Ureteral Stent (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741015663), received between Jun 2, 2021 and Jun 2, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
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
Device problems
- Device Handling Problem1
- Expiration Date Error1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2021Expiration Date Error; Device Handling Problem; Expiration Date Error; Device Handling Problem
IT WAS REPORTED THAT THE CUSTOMER HAD AN EXPIRED BARD OPTIMA URETERAL STENT 4.7 INTO 22 CM. IT WAS STATED THAT THE DEVICE EXPIRED ON 19APR2021 AND THE DEVICE WAS INSERTED ON (B)(6) 2021. PER FOLLOW UP INFORMATION RECEIVED FROM THE IBC VIA EMAIL ON 09JUN2021 IT WAS STATED THAT THE BARD INLAY OPTIMA STENT 4.7 INTO 22 CM WHICH WAS EXPIRED BY A WEEK OR TWO. THE SURGEON WANTED TO USE IT UP SO AS NOT TO WASTE AND KNOW IT WAS OUTDATED BY A SHORT TIME BUT THE SURGEON FELT IT WOULD NOT HURT THE PATIENT SO WENT AHEAD. THE REMAINING ONE WHICH WAS EXPIRED TWO DAYS AGO HAS BEEN REMOVED. IT IS NOT THE PHYSICIAN PRACTICE TO USE THE OUTDATED PRODUCTS BUT BECAUSE THE SURGEON INSISTED ON USING IT SO WENT AHEAD. IT WAS NOTED THAT THE SURGEON WROTE TO THE COMPANY TO JUST SEE WHETHER THERE WERE ANY ISSUES WITH USING A RECENTLY OUTDATED PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11921928 ↗
Other STENT, URETERAL devices
- Bard® InLay Optima® Ureteral Stent 788426C. R. Bard, Inc. · STENT, URETERAL1 recall100 reports
- Bard® InLay Optima® Ureteral Stent 788626C. R. Bard, Inc. · STENT, URETERAL122 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777626C. R. Bard, Inc. · STENT, URETERAL118 reports
- Bard® InLay® Ureteral Stent with HydroGlide™ Guidewire 777426C. R. Bard, Inc. · STENT, URETERAL108 reports
- Bard® InLay® Ureteral Stent 778626C. R. Bard, Inc. · STENT, URETERAL100 reports
- Percuflex™ Plus M0061752530Boston Scientific Corporation · STENT, URETERAL1 death99 reports
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Polaris™ Ultra M0061921330Boston Scientific Corporation · STENT, URETERAL71 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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