Amplatz G53556Recalls & reported problems
Cook Incorporated · Amplatz Stiff Fixed Core Wire Guide · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002535565), received between Jul 21, 2022 and Jul 21, 2022 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2022Break; Break
AS REPORTED, DURING A URETEROSCOPY INVOLVING URETERAL STENT PLACEMENT, THE TIP ON A AMPLATZ STIFF PTFE FIXED CORE WIRE GUIDE SEPARATED AND REMAINED INSIDE THE PATIENT'S KIDNEY. THE WIRE GUIDE WAS INSERTED THROUGH THE URETER ALONG WITH AN UNKNOWN MANUFACTURER'S SEMIRIGID URETEROSCOPE AND ADVANCED TO THE KIDNEY. AN UNKNOWN MANUFACTURER'S BALLISTIC LITHOCLAST WAS USED TO BREAK UP THE STONE. UPON REMOVAL OF THE GUIDE WIRE UNDER X-RAY VISUALIZATION, A 2 TO 3 CENTIMETER SECTION OF THE WIRE GUIDE SEPARATED AND REMAINED IN THE RENAL PELVIS. ATTEMPTED REMOVAL OF THE SEPARATED SECTION WAS UNSUCCESSFUL, AND THERE IS NO INFORMATION ON A FOLLOW UP PROCEDURE AT THIS TIME. ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 15076053 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.