Amplatz G07515Recalls & reported problems
Cook Incorporated · Amplatz Extra Stiff Whisker Wire Guide · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002075153), received between Dec 15, 2020 and Aug 24, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Protrusion/Extrusion3
- Defective Device2
- Contamination /Decontamination Problem1
- Device Contaminated During Manufacture or Shipping1
- Device Contamination with Chemical or Other Material1
- Packaging Problem1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 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 17618380 ↗MalfunctionMay 23, 2023Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping
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 16988395 ↗MalfunctionAug 8, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
AS REPORTED, WHILE FLUSHING AN AMPLATZ WHISKER EXTRA-STIFF SUPPORT WIRE GUIDE PRIOR TO USE DURING A BALLOON PULMONARY ANGIOPLASTY PROCEDURE, THE MANDRIL WAS FOUND TO BE PROTRUDING FROM THE DISTAL END OF THE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PACKAGE WAS NOT DAMAGED. ANOTHER WIRE OF THE SAME TYPE, FROM ANOTHER LOT, WAS USED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15184301 ↗MalfunctionJul 7, 2021Peeled/Delaminated; Peeled/Delaminated
AS REPORTED, PRIOR TO AN ENDOVASCULAR THROMBECTOMY A AMPLATZ WHISKER EXTRA-STIFF SUPPORT WIRE GUIDE HAD BEEN ALTERED CAUSING THE COATING OF THE TIP TO FLAKE OFF OR THE TIP TO BECOME DAMAGED. ANOTHER SAME DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE. THE PRODUCT DID NOT MAKE CONTACT WITH THE PATIENT AND NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. PRELIMINARY ANALYSIS OF THE DEVICE FOUND FOUND 2 CM OF THE INNER MANDRIL WERE PROTRUDING FROM THE COILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12127146 ↗MalfunctionDec 16, 2020Defective Device; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion; Packaging Problem; Defective Device; Device Contamination with Chemical or Other Material; Material Protrusion/Extrusion; Packaging Problem
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; No Consequences Or Impact To Patient
MAUDE report 11019209 ↗MalfunctionDec 15, 2020Defective Device; Defective Device
AS REPORTED, DURING A BALLOON DILATION AND USING A AMPLATZ WHISKER EXTRA-STIFF SUPPORT WIRE GUIDE, AN ABNORMALITY OCCURRED IN THE TIP OF THE WIRE GUIDE. THE ABNORMALITY WAS NOTED TO MOST LIKELY BE THE PROTRUSION OF THE CORE WIRE BUT IS NOT CERTAIN AND WAS NOTED DURING INSERTION INTO THE PATIENT'S BODY. ACCESS WAS GAINED THROUGH THE FEMORAL ARTERY. ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS HAVE BEEN REPORTED DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11007942 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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