Ascerta™ M0061456210Recalls & reported problems
Boston Scientific Corporation · Ureteral Stent · Class 2 · Implant
Data updated Oct 13, 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 08714729803058), received between Apr 14, 2017 and Apr 14, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Packaging Compromised” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Packaging Compromised1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2017Device Packaging Compromised; Device Packaging Compromised
NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT #3005099803-2017-01135 AND MFR. REPORT # 3005099803-2017-01136). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A POLARIS ULTRA STENT AND AN ASCERTA STENT WERE MEANT TO BE USED FOR A CYSTO STENT EXCHANGE PROCEDURE ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, IT WAS NOTICED DURING PREPARATION FOR THE PROCEDURE THAT THE INNER BOX CONTAINING THE STERILE DEVICE WAS CRUMPLED ON THE CORNER. REPORTEDLY, IT WAS ASSUMED THAT THE STERILITY OF THE PRODUCT WAS COMPROMISED. HOWEVER, THE INNER BOX WAS NOT OPENED TO CHECK THE STERILE POUCH CONTAINING THE DEVICE. IT IS UNKNOWN IF THE OUTER SHIPPING BOX WAS DAMAGED. THE DEVICE WAS NOT USED IN THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6494181 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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