Amplatz G09954Recalls & reported problems
Cook Incorporated · Amplatz Ultra Stiff Wire Guide · Class 2
All models of Amplatz (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00827002099548), received between Aug 27, 2020 and Aug 27, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
- Unraveled Material1
Patient problems
- Foreign Body In Patient1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material
IT WAS REPORTED A (B)(6) YEAR-OLD FEMALE PATIENT REQUIRED A AMPLATZ ULTRA-STIFF SUPPORT WIRE GUIDE FOR A DOUBLE J STENT REPLACEMENT PROCEDURE. THE OPERATOR REPORTED THE WIRE UNCOILED AND A PORTION OF THE COIL BROKE OFF IN THE URETER. THE FRAGMENTS WERE REMOVED DURING THE PROCEDURE WITH A URETEROSCOPE AND BIOPSY FORCEPS. THE STENT REPLACEMENT PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER THE FRAGMENTS WERE REMOVED, HOWEVER ADDITIONAL TIME UNDER ANESTHESIA WAS NOTED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Foreign Body In Patient; No Code Available
MAUDE report 10461258 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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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