Amplatz G53569Recalls & reported problems
Cook Incorporated · Amplatz Ultra Stiff Fixed Core Wire Guide Double Flexible · Class 2
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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002535695), received between Apr 10, 2018 and Aug 25, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Flaked” (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.
Reports received per month
Most reported problems
Device problems
- Flaked1
- Material Disintegration1
- Unraveled Material1
Patient problems
- Insufficient Information1
- No Consequences Or Impact To Patient1
- 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.
MalfunctionAug 25, 2025Flaked; Flaked
AS REPORTED, DURING URETEROSCOPY PROCEDURE, THE COATING OF THE 'AMPLATZ ULTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE' FLAKED OFF INTO THE PATIENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22883021 ↗MalfunctionApr 10, 2018Unraveled Material
THE COMPLAINANT REPORTED THAT THE AMPLATZ ULTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE BEGAN TO UNRAVEL INSIDE THE URETER WHEN FEEDING THE WIRE THROUGH A "RIGID" URETEROSCOPE. THE SCOPE AND DEVICE WERE PULLED OUT TOGETHER AND NO PIECE OF THE DEVICE WAS LEFT IN THE PATIENT. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE REPORTED PRODUCT PROBLEM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7419423 ↗MalfunctionApr 10, 2018Material Disintegration
IT WAS REPORTED THAT WHEN THE USER TRIED TO FEED THE STENT OVER THE AMPLATZ ULTRA STIFF PTFE DOUBLE FLEXIBLE WIRE GUIDE (OUTSIDE OF THE PATIENT), THE WIRE BEGAN TO SHRED. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7413412 ↗
Other Endoscopic guidewire, gastroenterology-urology devices
- HiWire G30474Cook Incorporated · Endoscopic guidewire, gastroenterology-urology82 reports
- Roadrunner G18154Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall18 reports
- Roadrunner G17542Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall9 reports
- Roadrunner G18153Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall6 reports
- Roadrunner G18155Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall3 reports
- Roadrunner G17539Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall2 reports
- Roadrunner G17540Cook Incorporated · Endoscopic guidewire, gastroenterology-urology1 recall0 reports
- Jagwire M00556580Boston Scientific Corporation · Endoscopic guidewire, gastroenterology-urology1 death49 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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