Amplatz G04237Recalls & reported problems
Cook Incorporated · Amplatz Extra Stiff Wire Guide · Class 2
All models of Amplatz (42)
Data updated Oct 18, 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 00827002042377), received between Oct 4, 2017 and May 5, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping2
- Device Contamination with Chemical or Other Material1
- Flaked1
- Unraveled Material1
Patient problems
- No Patient Involvement3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A HAIR-LIKE SUBSTANCE WAS FOUND INSIDE THE PACKAGING OF AN AMPLATZ EXTRA STIFF SUPPORT WIRE GUIDE. UPON OPENING THE PACKAGE, A NURSE NOTICED THE FOREIGN MATTER PRIOR TO A BILIARY DRAINAGE PROCEDURE, DURING WHICH A DRAINAGE TUBE WAS TO BE INSERTED PERCUTANEOUSLY INTO THE RIGHT BILE DUCT BRANCH. THE PROCEDURE WAS COMPLETED USING A NEW SAME-LIKE DEVICE. IT WAS CONFIRMED THAT NO DAMAGE TO THE PACKAGE WAS NOTICED, AND THE DEVICE WAS STORED VERTICALLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21963657 ↗MalfunctionJun 28, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE AMPLATZ EXTRA STIFF SUPPORT WIRE GUIDE HAD A FOREIGN OBJECT THAT LOOKED LIKE A HUMAN HAIR INSIDE THE SEALED PACKAGE. THIS WAS NOTICED BY A FACILITY STAFF, SO THEY STOPPED USING THE DEVICE. THE PLANNED PROCEDURE WAS COMPLETED BY USING ANOTHER COOK DEVICE. PHOTOS OF THE COMPLAINT DEVICE PROVIDED BY THE CUSTOMER CONFIRM THE FAILURE. AS REPORTED, THE DEVICE DID NOT MAKE PATIENT CONTACT AND NO HARM HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19633963 ↗MalfunctionJul 18, 2019Unraveled 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 Patient Involvement
MAUDE report 8802192 ↗MalfunctionFeb 26, 2018Flaked; Flaked
THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE OPERATOR WENT TO USE THE AMPLATZ EXTRA STIFF SUPPORT WIRE GUIDE, IT WAS OBSERVED THAT THE OUTER COATING AT THE J END OF THE DEVICE WAS DAMAGED. THE NATURE OF THE DAMAGE WAS NOT ELABORATED UPON BY THE CUSTOMER. THE DEVICE WAS REPORTEDLY NOT USED IN THE PATIENT. WHEN THE DEVICE WAS RETURNED AND EVALUATED, THIS DAMAGE WAS CONFIRMED TO SPECIFICALLY BE A FLAKING OF THE COATING. THE INVESTIGATION OF THE DEVICE IS COMPLETE AS OF (B)(6) 2018.
Patient problems: No Patient Involvement
MAUDE report 7298198 ↗MalfunctionOct 4, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE INTERNATIONAL CUSTOMER REPORTED THAT A HAIR WAS PRESENT IN THE PACKAGING OF THE AMPLATZ EXTRA STIFF SUPPORT WIRE GUIDE. THE CUSTOMER CONFIRMED THAT NO PATIENT INJURY OCCURRED. IT IS UNKNOWN WHEN THE HAIR WAS DISCOVERED, AND IF THE PRODUCT WAS OPENED AND USED. NO FURTHER INFORMATION WAS MADE AVAILABLE. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RECEIVED FOR EVALUATION.
Patient problems: No Patient Involvement
MAUDE report 6914608 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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