Amplatz G10168Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002101685), received between Jun 13, 2019 and May 20, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
- Difficult to Remove1
- Material Protrusion/Extrusion1
Patient problems
- Cardiac Perforation1
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionMay 20, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING REMOVAL OF AN AMPLATZ ULTRA-STIFF SUPPORT WIRE GUIDE, THE INNER MANDRIL PROTRUDED THROUGH THE COATING OF THE WIRE GUIDE. ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 14462822 ↗InjuryMar 25, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED AN AMPLATZ ULTRA-STIFF SUPPORT WIRE GUIDE WAS USED IN A FEMALE PATIENT FOR AN UNKNOWN PROCEDURE. AFTER THE FIRST INSERTION, THE WIRE GOT STUCK IN ANGIOGRAPHIC CATHETER. ADDITIONAL INFORMATION RECEIVED (B)(6) 2020 STATED THERE WAS NO DIFFICULTY IN PLACING WIRE THROUGH CATHETER INITIALLY OR WITH WITHDRAWAL, BUT THERE WAS APPROXIMATELY 1.5 CM OF WIRE EXTENDING THROUGH THE LUMEN OF THE CATHETER WHEN THE WIRE BECAME STUCK IN THE MYOCARDIUM. AT THAT TIME, WE COULD NOT WITHDRAW THE WIRE OR CATHETER. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: Cardiac Perforation
MAUDE report 9880728 ↗MalfunctionJun 13, 2019Defective Device; Defective Device
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8696439 ↗
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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