Salle G32774Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002327740), received between Feb 25, 2022 and Mar 25, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2025Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21690507 ↗
• InjuryMar 5, 2025Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THAT DURING A PYELOPLASTY PROCEDURE, THE WIRE GUIDE INCLUDED IN THE 'SALLE INTRAOPERATIVE PYELOPLASTY STENT SET' BECAME SNAGGED INSIDE THE STENT MAKING IT DIFFICULT TO REMOVE. THE PATIENT HAS SUBSEQUENTLY PASSED SOME GREEN MATERIAL IN THE URINE WHICH IS THE SAME COLOR AS THE COATING. AS REPORTED, THE STENT WAS INSERTED OVER THE GUIDEWIRE WHICH HAD BEEN CUT TO REMOVE THE SECOND COIL. UPON WITHDRAWAL, IT INITIALLY CAME OUT SMOOTHLY BUT THEN BECAME DIFFICULT TO REMOVE CAUSING THE STENT TO CONCERTINA AND COIL UP. THE WIRE WAS EVENTUALLY REMOVED, THE STENT WAS CHECKED FOR PROPER POSITIONING AND THE PROCEDURE WAS COMPLETED. THE PATIENT SEEMED FINE AND WAS DISCHARGED FROM THE HOSPITAL. LATER, THE BABY HAD A GREEN GRITTY SEDIMENT IN THE NAPPY. THE PARENTS CONTACTED THE PHYSICIAN, AND THE BABY WAS BROUGHT BACK TO THE HOSPITAL FOR A PLAIN X-RAY TO ENSURE THERE WASN'T ANYTHING LEFT IN THE BLADDER. THE STENT WAS REMOVED 3 DAYS EARLIER THAN PLANNED, WHERE IT WAS FOUND THAT IT HAD A SLIGHT GREEN TINGE TO IT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Foreign Body In Patient; Hematuria

  MAUDE report 21531868 ↗
• InjuryFeb 25, 2022Break; Break

  AS REPORTED, DURING A PYELOPLASTY ON (B)(6) 2022, A SALLE PYELOPLASTY STENT SET WAS PLACED WITHOUT A WIRE. ON (B)(6) 2022, THE STENT WAS REMOVED WITH THE USE OF PROBE ABLATION, BUT THE DEVICE WAS DISCOVERED TO BE SEPARATED, WITH HALF OF THE DEVICE REMAINING IN THE PATIENT'S KIDNEY. DURING ANOTHER PROCEDURE THE SAME DAY, THE REMAINING DEVICE SEGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT VIA SURGICAL INCISION. THE STENT WAS NOT ENCRUSTED. THE PATIENT WAS HOSPITALIZED ONE ADDITIONAL DAY FOLLOWING THE STENT REMOVAL. NO ADVERSE AFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13599281 ↗