Amplatz G09710Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002097100), received between Mar 5, 2018 and Nov 9, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Operational Issue” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

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

  Patient problems: Foreign Body In Patient

  MAUDE report 12779661 ↗
• InjuryMar 5, 2018Device Operational Issue; Device Operational Issue

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A LEFT SIDED URETERIC STENT PROCEDURE IN WHICH A ULTRATHANE AMPLATZ URETERAL STENT SET WAS EMPLOYED, THE BLACK PUSHER WOULD NOT ADVANCE UP TO THE RADIOPAQUE BAND OF THE DEVICE. AS A RESULT, THE PHYSICIAN USED THE STENT DELIVERY SYSTEM WITH THE BLACK PUSHER NOT PROPERLY ADVANCED UP TO THE RADIOOPAQUE BAND. THE PHYSICIAN ADVANCED THE STENT INTO THE PATIENT AND CUT THE STRING BEFORE THE STENT WAS IN PLACE, AND THE STENT WAS DEPLOYED IN THE INCORRECT POSITION. THE DISTAL PIGTAIL WAS IN THE URETER, AND THE PROXIMAL PIGTAIL WAS OUTSIDE OF THE KIDNEY (AND NEAR THE SKIN SURFACE). THE CUSTOMER BELIEVES THIS OCCURRED BECAUSE THE BLACK PUSHER COULD NOT BE USED EFFECTIVELY TO PLACE THE STENT. THE PATIENT WAS REQUIRED TO RETURN TO THE DEPARTMENT FOR A SECOND ATTEMPT AT THE LEFT SIDED URETERIC STENT INSERTION, WHICH WAS PERFORMED BY ANOTHER PHYSICIAN ON (B)(6) 2018. THE SECOND STENT WAS SUCCESSFULLY IMPLANTED INTO THE PATIENT. THE COMPLAINT DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 7315347 ↗