Amplatz G04003Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002040038), received between Jun 19, 2019 and Jul 23, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).
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
- Device Contaminated During Manufacture or Shipping2
- Material Frayed1
- Material Protrusion/Extrusion1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579442 ↗MalfunctionJul 11, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT ADDITIONAL INFORMATION RECEIVED 24JUL2023, IT WAS CONFIRMED THAT NO PATIENT CONTACT WAS MADE WITH DEVICE. THE CIRCULATOR DISCOVERED THE ISSUE BEFORE THE SURGERY CASE AND THE PACKAGING WAS NOT OPENED. ANOTHER NEW SAME DEVICE WAS OPENED FOR THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17302314 ↗MalfunctionMay 24, 2022Unraveled Material; Unraveled Material
IT WAS REPORTED AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE UNRAVELED. DURING ATTEMPTED REMOVAL FROM A CHOLECYSTOSTOMY TUBE, THE WIRE GUIDE UNRAVELED. THE PATIENT DID NOT HAVE TORTUOUS, CALCIFIED, OR SCARRED ANATOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER, SIMILAR DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14492826 ↗MalfunctionJun 10, 2021Material Frayed; Material Frayed
IN ADDITIONAL INFORMATION RECEIVED ON 24JUN2021, IT WAS CONFIRMED THAT ANOTHER WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11973531 ↗MalfunctionJun 19, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 8711832 ↗
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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