Amplatz G27035Recalls & reported problems
Cook Incorporated · Amplatz 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 00827002270350), received between Oct 11, 2018 and Dec 7, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (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.
Most reported problems
Device problems
- Unraveled Material2
- Material Integrity Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- 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.
MalfunctionDec 7, 2020Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10959613 ↗MalfunctionJan 21, 2019Material Integrity Problem; Material Integrity Problem
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 8264153 ↗MalfunctionOct 11, 2018Unraveled Material; Unraveled Material
IT WAS REPORTED, DURING A BALLOON VALVULOPLASTY ON A (B)(6) YEAR OLD MALE DOG, THE AMPLATZ STIFF SUPPORT WIRE GUIDE BECAME LODGED IN THE BALLOON CATHETER (MANUFACTURER NOT SPECIFIED) RESULTING IN DAMAGE TO BOTH THE COMPLAINT DEVICE AND THE UNKNOWN BALLOON CATHETER. THE VETERINARIAN ATTEMPTED TO REMOVE IT BUT COULDN'T. THE PROCEDURE WAS COMPLETED AT THAT POINT. NO ADDITIONAL DEVICES WERE REQUIRED. UPON RECEIPT BY THE MANUFACTURER, PRELIMINARY VISUAL INSPECTION REVEALED A LENGTH OF COIL WAS MISSING FROM THE AMPLATZ STIFF SUPPORT WIRE GUIDE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE ANIMAL'S BODY. THE ANIMAL DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE ANIMAL DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7957810 ↗
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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