Amplatz G03562Recalls & reported problems
Cook Incorporated · Amplatz Extra Stiff Wire Guide · Class 2
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00827002035621), received between Jul 25, 2017 and Sep 15, 2025 — classified as 1 injury, 19 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (10 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Protrusion/Extrusion10
- Break3
- Unraveled Material3
- Contamination /Decontamination Problem1
- Deformation Due to Compressive Stress1
- Device Contaminated During Manufacture or Shipping1
- Material Frayed1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient3
- No Patient Involvement3
- Insufficient Information1
- Thrombosis1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
AS REPORTED, UPON OPENING THE UNDAMAGED DEVICE PACKAGE, PRIOR TO USE FOR AN UNSPECIFIED PROCEDURE INVOLVING PLACEMENT OF A STENT, THE TIP OF AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE WAS FOUND TO BE DAMAGED. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THE MANDRIL PROTRUDING FROM THE WIRE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23051634 ↗MalfunctionSep 11, 2025Break; Break
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 23025953 ↗MalfunctionAug 19, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
AS REPORTED, FOREIGN MATTER RESEMBLING A HAIR WAS NOTED WITHIN AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDES STERILE PACKAGE. THIS WAS NOTED WITHIN A DISTRIBUTION FACILITY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22842726 ↗MalfunctionOct 28, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
AS REPORTED, UPON OPENING THE PACKAGING OF A AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE, THE WIRE WAS KINKED AND "DRAWING AT THE CIRCULAR BEND OF THE WIRE GUIDE TIP". THE USER DID NOT ATTEMPT TO SHAPE THE GUIDEWIRE TIP. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE. A PHOTO PROVIDED BY THE CUSTOMER SHOWS POSSIBLE MANDRIL PROTRUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20543746 ↗MalfunctionOct 1, 2024Material 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 20348030 ↗MalfunctionAug 26, 2024Material 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 20067113 ↗MalfunctionDec 12, 2023Unraveled Material; Unraveled Material
AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE, AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE ¿CAME APART¿. AN UNSPECIFIED BALLOON WAS INSERTED INTO THE PATIENT FOR ANGIOPLASTY AND UPON ATTEMPTED REMOVAL OF THE BALLOON, THE WIRE WAS GETTING PULLED BACK WITH THE BALLOON. THE PHYSICIAN THEN ATTEMPTED TO EXCHANGE THE WIRE TO MAINTAIN PLACEMENT. REPORTEDLY, THE PHYSICIAN ¿FELT SOMETHING WEIRD¿ UPON ATTEMPTED REMOVAL OF THE WIRE, AND THEREFORE PULLED THE BALLOON AND WIRE OUT TOGETHER. UPON INVESTIGATION OF THE WIRE, THE USER REPORTED THAT THE FIRST SEGMENT OF THE WIRE WAS ¿COMING APART¿ BUT DID NOT BREAK OFF. ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18312819 ↗MalfunctionSep 18, 2023Unsealed Device Packaging; Unsealed Device Packaging
AS REPORTED, UPON RECEIPT AND INSPECTION OF AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE, ONE END OF THE STERILE PACKAGE WAS NOT SEALED. THE DEVICE WAS NOT USED, AND THERE WAS NO IMPACT TO ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17765364 ↗MalfunctionJul 27, 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 17406031 ↗MalfunctionDec 16, 2022Material Frayed; Material Frayed
ADDITIONAL INFORMATION AND CLARIFICATION OF THE TERM "FRAYED" WAS RECEIVED 18DEC2022. THE WIRE TIP WAS "SLIGHTLY TURNED OUTWARD".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15997393 ↗MalfunctionFeb 28, 2022Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress
AS REPORTED, THE TIP OF A AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE WAS DISCOVERED "BROKEN/SNAPPED" WHEN REMOVING THE DEVICE FROM THE PACKAGING. NO DAMAGE WAS OBSERVED TO THE DEVICE PACKAGING. A NEW DEVICE WAS USED TO COMPLETE THE ENDOVASCULAR THERAPY PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13618238 ↗MalfunctionNov 7, 2021Unraveled Material; Material Protrusion/Extrusion; Unraveled Material; Material Protrusion/Extrusion
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12762843 ↗MalfunctionApr 15, 2021Break; Break
AS REPORTED, DURING A CARDIAC CATHETERIZATION INVOLVING ANGIOGRAPHY OF THE PULMONARY ARTERY VIA RIGHT-SIDED VENOUS ACCESS, AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE BROKE WITHIN ANOTHER MANUFACTURER'S PIGTAIL CATHETER. THE WIRE REPORTEDLY DID NOT ADVANCE PROPERLY WITHIN THE CATHETER AND BECAME STUCK AND UNABLE TO REMOVE FROM THE CATHETER. THE WIRE WAS IN PLACE FOR APPROXIMATELY FIVE MINUTES. THE ANATOMY WAS NOT CALCIFIED OR TORTUOUS. STENTS WERE PRESENT IN THE PULMONARY ARTERY. THE WIRE AND CATHETER WERE REMOVED TOGETHER FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH NEW PRODUCTS. THERE WAS NO HARM TO THE PATIENT. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11670493 ↗MalfunctionDec 1, 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 10927138 ↗MalfunctionNov 10, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10819431 ↗MalfunctionJun 8, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
ADDITIONAL INFORMATION WAS RECEIVED ON 03AUG2020 NOTING THAT THEY DID NOT NOTE ANY DAMAGE ON THE DEVICE PACKAGING AND THE STORAGE CONDITION FOR THE COMPLAINT DEVICE WAS AS REQUIREMENT.
Patient problems: No Patient Involvement
MAUDE report 10128893 ↗MalfunctionApr 10, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
ADDITIONAL INFORMATION WAS RECEIVED 09APR2020. THE PACKAGE OF THE DEVICE WAS NOT DAMAGED.
Patient problems: No Patient Involvement
MAUDE report 9948288 ↗MalfunctionDec 11, 2019Material 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 Consequences Or Impact To Patient
MAUDE report 9451246 ↗MalfunctionDec 11, 2018Contamination /Decontamination Problem; Contamination /Decontamination 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 8151663 ↗InjuryJul 25, 2017Retraction Problem; Retraction Problem
IT IS ALLEGED THAT AN COOK AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE WAS BEING USED IN CONJUNCTION WITH A ZILVER PTX 35 DRUG-ELUTING STENT (ANOTHER MANUFACTURER) DURING A RIGHT-LEG ANGIOGRAM WHEN THE TWO DEVICES MALFUNCTIONED. IT WAS REPORTED THAT AFTER DEPLOYING ONE STENT IN THE PATIENT'S SFA ANOTHER STENT OF THE SAME KIND WAS PLACED. HOWEVER, THE ZILVER PTX DEPLOYMENT SYSTEM OF THE SECOND STENT BECAME "CAUGHT" ON THE WIRE GUIDE AS IT WAS BEING REMOVED. IN ORDER TO REMOVE THE DEPLOYMENT DEVICE, THE WIRE GUIDE HAD TO BE REMOVED ALONGSIDE THE ZILVER PTX DEPLOYMENT SYSTEM. A NEW AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE WAS INSERTED AND A "MUSTANG BALLOON" WAS USED TO POST-DILATE THE SECOND ZILVER PTX 35 DRUG-ELUTING STENT. SOON AFTER, IT WAS OBSERVED THAT A CLOT HAD DEVELOPED IN THE PROXIMAL STENT AND TPA WAS ADMINISTERED. USING AN "ANGIODYNAMICS UNIFUSE CATHETER SYSTEM," FOLLOWED BY THE USE OF AN "ANGIO JET MACHINE" IN THE PROXIMAL STENT. ALLEGEDLY, THE CLOT THEN MIGRATED THROUGH BOTH STENTS, TO THE PATIENT'S TRIFURCATION. IN ADDITION, IT WAS REPORTED THAT THROMBUS WAS ALSO SEEN IN THE POPLITEAL VESSEL, AND THE PATIENT UNDERWENT A FEMORAL-POPLITEAL BYPASS SURGERY SOON AFTER.
Patient problems: Thrombosis
MAUDE report 6741175 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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.