Porges Coloplast BCHF74Recalls & reported problems
Coloplast A/S · ImaJin™ Double loop ureteral stent silicone hydro-coated open/open CH FR 07 length 26 cm with steerable pusher · Class 2 · Implant
All models of Porges Coloplast (79)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708932704595), received between Nov 11, 2024 and Nov 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE AVAILABLE INFORMATION, THE STENT TORE WHEN TRYING TO THREAD ONTO THE WIRE. ADDITIONAL STENTS WERE NEEDED TO BE OPENED WHICH RESULTED IN LONGER OPERATION TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20656144 ↗MalfunctionNov 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE AVAILABLE INFORMATION, THE STENT TORE WHEN TRYING TO THREAD ONTO THE WIRE. ADDITIONAL STENTS WERE NEEDED TO BE OPENED WHICH RESULTED IN LONGER OPERATION TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20654943 ↗
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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