Amplatz G27032Recalls & 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
- 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 00827002270329), received between Sep 26, 2018 and Jul 6, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (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
- Unraveled Material3
- Material Separation1
- Peeled/Delaminated1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient2
- 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 6, 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 Known Impact Or Consequence To Patient
MAUDE report 10233071 ↗MalfunctionDec 19, 2019Unraveled Material; Unraveled Material
AS REPORTED, DURING A "DRAINAGE" PROCEDURE, AN AMPLATZ STIFF SUPPORT WIRE GUIDE EXPERIENCED "REWINDING OF THE SHEATH IN PER INTERVENTIONAL BY FRICTION IN CATHETER." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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. CLARIFICATION REGARDING THIS EVENT HAS BEEN REQUESTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9495120 ↗MalfunctionMay 1, 2019Material Separation; Material Separation
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 8571806 ↗MalfunctionNov 8, 2018Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED, UPON EXAMINATION OF THE AMPLATZ STIFF SUPPORT WIRE GUIDE, IT PRESENTED WITH A BEND AND THE COATING WAS PEELING OFF AT THE POINT OF THE BEND. THIS DEVICE NEVER MADE PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 8051486 ↗MalfunctionSep 26, 2018Unraveled Material
THE COMPLAINANT REPORTED THAT THE AMPLATZ STIFF SUPPORT WIRE GUIDE UNRAVELED DURING VESSEL DILATION. THIS OCCURRED DURING A TUNNELED LINE INSERTION INSIDE OF THE JUGULAR VEIN. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7909568 ↗
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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