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Amplatz G09709Recalls & reported problems

Cook Incorporated · Amplatz Ureteral Stent Set Ultrathane · Class 2 · Implant

All models of Amplatz (42)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002097094), received between Mar 21, 2017 and Apr 11, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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

Device problems

  • Difficult or Delayed Positioning1
  • Difficult to Advance1
  • Fracture1
  • Material Separation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionApr 11, 2023Difficult or Delayed Positioning; Material Separation; Difficult or Delayed Positioning; Material Separation

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16712385 ↗
  • MalfunctionSep 11, 2020Difficult to Advance; Difficult to Advance

    IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE AMPLATZ URETERAL STENT SET FOR A URETERIC STENT INSERTION PROCEDURE. DURING THE PROCEDURE, THE OPERATOR STATED THEY COULD NOT FLUSH THE DEVICE AND THE BLACK INTRODUCER WOULD NOT MOVE DOWN TO MEET THE STENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10524496 ↗
  • InjuryMar 21, 2017Fracture; Fracture

    INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS ANTEGRADE URETERIC STENT PLACEMENT ON (B)(6) 2017. THE PROCEDURE WAS REPORTED TO BE UNEVENTFUL AND THE PATIENT WAS DISCHARGED. THE PATIENT RETURNED FOR FOLLOW-UP WITH NEPHROSTOGRAM ON (B)(6) 2017. NEPHROSTOGRAM RESULTS SHOW A FRACTURED STENT WITHIN THE URETER PROXIMAL TO THE KIDNEY. THE CUSTOMER OPINES THAT A STONE MAY HAVE CAUSED THE FRACTURE DURING STENT PLACEMENT. THE PATIENT IS REPORTEDLY SCHEDULED FOR UROLOGIC SURGERY TO REMOVE AND REPLACE THE FRACTURED STENT. IT IS NOT KNOWN AS OF THE DATE OF THIS REPORT IF THE PATIENT UNDERWENT SURGERY. PATIENT HAS AN EXTERNAL DRAIN FOR DRAINING URINE FROM KIDNEY. NO FURTHER INFORMATION WAS RECEIVED. THE ACTUAL DEVICE INVOLVED IS NOT AVAILABLE FOR EXAMINATION.

    Patient problems: No Code Available

    MAUDE report 6421252 ↗

Other STENT, URETERAL devices

All STENT, URETERAL devices →

Sources and updates

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