Amplatz G03330Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002033306), received between Aug 4, 2020 and Aug 29, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Stretched” (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
- Stretched1
- Unraveled Material1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2023Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED, DURING PRODUCT INVENTORY, THE BOTTOM SEAL WAS FOUND TO BE MISSING FROM AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE'S STERILE PACKAGE. NO DAMAGE WAS NOTED TO THE SHIPPING BOX. THE DEVICE DID NOT MAKE CONTACT WITH ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17641478 ↗MalfunctionAug 4, 2020Stretched; Unraveled Material; Stretched; Unraveled Material
AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN UNKNOWN PROCEDURE, AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE WAS FOUND TO BE STRETCHED AND UNRAVELED FROM THE MANDRIL. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT, AND ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE HAS BEEN NO REPORT THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10361163 ↗
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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