Amplatz G03565Recalls & 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
- 12
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00827002035652), received between Sep 20, 2018 and Aug 26, 2026 — classified as 1 death, 11 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem3
- Device Contaminated During Manufacture or Shipping3
- Unraveled Material2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Contamination with Chemical or Other Material1
- Flaked1
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- No Known Impact Or Consequence To Patient2
- Hemorrhage/Blood Loss/Bleeding1
- No Patient Involvement1
- Perforation of Vessels1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50460672 ↗DeathMar 2, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED TO COOK BY ANOTHER DEVICE MANUFACTURER (ABBOTT), DURING AN UNSPECIFIED PROCEDURE INVOLVING A PATIENT WITH LEFT ATRIAL FLUTTER, A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE PERFORATED THE ILIAC VEIN DURING INSERTION OF THE WIRE. UPON INSERTION OF AN UNKNOWN SHEATH, THE PERFORATION REPORTEDLY ENLARGED. PER THE REPORTER, A CORONARY ANGIOGRAM WAS PERFORMED. THE PERFORATION RESULTED IN BLEEDING. THE PATIENT DIED THREE DAYS AFTER THE PROCEDURE. THE PHYSICIAN STATED THAT THE WIRE WAS ¿TOO RIGID¿ AND THE PATIENT HAD FRAGILE VEINS, WHICH PER THE PHYSICIAN, CAUSED THE PERFORATION. PER THE OTHER MANUFACTURER, THERE WERE ¿NO PERFORMANCE ISSUES WITH THE SHEATH¿. THERE HAS BEEN NO ALLEGED MALFUNCTION OF THE COOK WIRE GUIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 24481431 ↗MalfunctionFeb 20, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED BY THE DISTRIBUTOR, A HAIR-LIKE FOREIGN MATTER WAS FOUND IN THE PACKAGING OF A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE. THIS WAS FOUND PRIOR TO DELIVERY TO THE HOSPITAL, THEREFORE, THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21422722 ↗MalfunctionOct 25, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, WHILE PREPARING FOR A LEAD EXTRACTION PROCEDURE, A HAIR WAS FOUND IN THE PACKAGING OF A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE. THE PACKAGE WAS NEVER OPENED, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS REPORTED DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20536196 ↗MalfunctionMay 6, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT FOREIGN MATTER RESEMBLING A HAIR WAS FOUND IN THE PACKAGING OF A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE UPON ARRIVAL TO THE WAREHOUSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19255436 ↗MalfunctionJan 11, 2023Material 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 16136772 ↗MalfunctionAug 26, 2022Unraveled Material; Unraveled Material
AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, THE TIP OF A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE WAS FOUND TO BE STRETCHED UPON OPENING THE DEVICE PACKAGE. THE PACKAGE WAS NOT DAMAGED. THE WIRE WAS NOT USED, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15300062 ↗MalfunctionJul 12, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED, PRIOR TO USE FOR AN UNKNOWN PROCEDURE, A HAIR WAS NOTED IN A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE'S STERILE PACKAGE. THIS WAS NOTED IMMEDIATELY UPON OPENING THE PACKAGE. THE DEVICE WAS NOT USED. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14988193 ↗MalfunctionJun 3, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11930053 ↗MalfunctionAug 31, 2020Flaked; Contamination /Decontamination Problem; Flaked; Contamination /Decontamination Problem
AS REPORTED, DURING AN UNKNOWN PROCEDURE, FOREIGN MATTER WAS FOUND ON THE TIP OF A SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE. THIS WAS OBSERVED UPON OPENING THE PACKAGE OF THE DEVICE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 10474177 ↗MalfunctionSep 20, 2018Break; Mechanical Jam
IT WAS REPORTED THAT THE SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE BECAME STUCK IN THE SHEATH AFTER RELEASING A STENT. THE DEVICE WAS LATER FOUND TO HAVE SIGNIFICANT DAMAGE TO ITS HYDROPHILIC COATING. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7895795 ↗MalfunctionSep 20, 2018Unraveled Material; Material Split, Cut or Torn
IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE INTRODUCER (THE PROCEDURE WAS ABANDONED FOR PHYSIOLOGICAL REASONS), THE NYLON SPLIT AND THE AMPLATZ COILS BEGAN TO UNRAVEL. THE DEVICES WERE REMOVED AS A UNIT, NO FRAGMENTS WERE LEFT IN THE PATIENT, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. IT WAS FURTHER CONFIRMED THAT THE COATING WAS TORN AND THE COIL WAS ELONGATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7894603 ↗
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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