Amplatz G04001Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002040014), received between Apr 25, 2017 and Jan 31, 2023 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (3 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.
Most reported problems
Device problems
- Material Protrusion/Extrusion3
- Detachment of Device or Device Component1
- Difficult to Advance1
- Unintended Movement1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- Cardiac Perforation1
- Cardiac Tamponade1
- Pericardial Effusion1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2023Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; 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 Clinical Signs, Symptoms or Conditions
MAUDE report 16271011 ↗MalfunctionSep 16, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
AS REPORTED, UPON OPENING THE PACKAGE FOR AN UNKNOWN PROCEDURE, THE MANDRIL WAS FOUND TO BE PROTRUDING FROM A KINKED AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE. THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15440501 ↗InjuryMar 5, 2019Unintended Movement; Unintended Movement
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion
MAUDE report 8391455 ↗MalfunctionSep 20, 2018Difficult to Advance; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE PHYSICIAN HAD THE AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE WAS BEING USED FOR ENDOVASCULAR THERAPY IN THE SUPERFICIAL FEMORAL ARTERY WITH A CONTRALATERAL APPROACH, BUT THE WIRE WOULD NOT ADVANCE THROUGH THE SHEATH. IT WAS REPLACED WITH ANOTHER MANUFACTURER'S WIRE, AND THE PROCEDURE WAS COMPLETED. IT WAS LATER FOUND THAT THE GUIDEWIRE'S INNER MANDREL WAS PROTRUDING FROM THE COIL. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7895828 ↗MalfunctionApr 25, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE PHYSICIAN OBSERVED THE STAINLESS STEEL MANDRIL EXPOSED OUTSIDE THE POLYTETRAFLUOROETHYLENE (PTFE) ON THE AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE WHILE HE WAS SHAPING THE WIRE. THIS OCCURRED PRIOR TO ANY PATIENT CONTACT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AND DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6520945 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page