Amplatz G08280Recalls & reported problems
Cook Incorporated · Amplatz Extra Stiff Wire Guide · 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 00827002082809), received between Jul 25, 2017 and Sep 24, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (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 Frayed1
- Material Protrusion/Extrusion1
- Material Separation1
- Material Twisted/Bent1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2018Material Frayed; Material Twisted/Bent
IT WAS REPORTED THAT THE AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE WAS FOUND TO HAVE A BENT TIP AND TO BE FRAYING/FUZZY UPON OPENING THE PACKAGE. IT DID NOT MAKE PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7902338 ↗MalfunctionSep 20, 2018Material Protrusion/Extrusion
IT WAS REPORTED THAT THE AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE WAS FOUND TO HAVE ITS CORE WIRE PROTRUDING FROM THE COILS WHILE THE PHYSICIAN ATTEMPTED TO ALTER ITS TIP CONFIGURATION. IT DID NOT MAKE PATIENT CONTACT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7895960 ↗MalfunctionJul 25, 2017Material Separation; Material Separation
AN INTERNATIONAL CUSTOMER REPORTED THAT THE TIP OF THE AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE MAY HAVE SEPARATED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6740023 ↗
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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