Amplatz G06801Recalls & reported problems
Cook Incorporated · Amplatz Extra Stiff Wire Guide · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002068018), received between Sep 24, 2018 and Feb 15, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (4 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Aug 16, 2022Open, Classified
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Z-1824-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Material Protrusion/Extrusion4
- Unraveled Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 15, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
AS REPORTED, DURING AN ENDOVASCULAR THERAPY PROCEDURE, THE USER CURVED THE TIP OF AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE AND THE CORE WIRE WAS STICKING OUT. THE DEVICE DID NOT MAKE PATIENT CONTACT AND AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16380594 ↗MalfunctionDec 6, 2022Material Protrusion/Extrusion; 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 15925649 ↗MalfunctionJul 14, 2022Unraveled Material; Unraveled Material
AS REPORTED, UPON OPENING THE PACKAGING OF AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE, PRIOR TO USE DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIAL DRAINAGE PROCEDURE, THE WIRE WAS NOTED TO BE UNRAVELED AT THE TIP. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED. THE PATIENT RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15014079 ↗MalfunctionNov 8, 2021Unraveled 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 Clinical Signs, Symptoms or Conditions
MAUDE report 12771530 ↗MalfunctionOct 6, 2021Unraveled 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 Clinical Signs, Symptoms or Conditions
MAUDE report 12583020 ↗MalfunctionSep 27, 2018Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED, THE PHYSICIAN NOTICED CORE WIRE PROTRUSION ON THE AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE PRIOR TO USE SO HE USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. NO PATIENT ADVERSE EFFECT HAS BEEN REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7913941 ↗MalfunctionSep 24, 2018Material Protrusion/Extrusion
IT WAS REPORTED THAT THE AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE WAS FOUND TO HAVE ITS CORE WIRE PROTRUDING FROM THE COIL UPON OPENING THE PACKAGE. IT DID NOT MAKE PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7901754 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.